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DRUGS APPROVED IN
2010



Compiled by: Naveen Kumar
Ampyra

   Drug: Ampyra (dalfampridine)
    Indication: Multiple sclerosis
    Companies: Acorda Therapeutics
    Approval Date: January 22
   Drug type: Small molecule
   Summary: Acorda's MS drug focused on helping
    patients' walking difficulties, and according to the
    company, is the only drug that can increase walking
    speeds in those affected. The drug's approval sparked
    almost immediate buyout rumors for Acorda. Although
    none came to fruition, the company has a
    manufacturing deal with Elan for the drug.
Asclera

   Drug: Asclera (polidocanol)
    Indication: Varicose veins
    Companies: Chemische Fabrik Kresussler
    Approval Date: March 30
   Drug Type: Small molecule
   Summary: The FDA approved Chemische Fabrik
    Kresussler's drug in March for spider veins
    (varicose veins smaller than 1 mm in diameter)
    and reticular veins (those 1 to 3 mm in diameter)
    in March. The drug attacks the vein's cellular wall
    lining, causing the vessel to close.
Carbaglu

   Drug: Carbaglu (carglumic acid)
    Indication: NAGS deficiency
    Companies: Orphan Europe
    Approval Date: March 18
   Drug type: Small molecule
   Summary: Despite early concerns that study designs
    could have interfered with drug testing results, the
    FDA unanimously approved Carbaglu for patients with
    N-acetylglutamate
    synthase, or NAGS, deficiency, which causes excess
    amounts of ammonia in the blood. The drug is a
    Carbamoyl Phosphate Synthetase 1 activator
Egrifta

   Drug: Egrifta (tesamorelin)
    Indication: HIV
    Companies: Theratechnologies
    Approval Date: November 10
   Drug type: Small molecule
   Summary: Egrifta was approved to treat
    lipodystrophy, a condition common in those taking
    antiretroviral drugs to treat HIV. Lipodystrophy
    causes excess fat buildup particularly in the
    abdominal region. The growth hormone releasing
    factor (GRF) drug is administered via a daily
    injection, and was more effective than a placebo
    injection in clinical trials
EllaOne

   Drug: EllaOne (ulipristal acetate)
    Indication: Emergency contraceptive
    Companies: HRA Pharma, Watson
    Approval Date: August 13
   Drug type: Small molecule
   Summary: Billed as the new "morning-after pill,"
    EllaOne. Like Plan B, the pill is taken
    after intercourse to reduce the risk of
    pregnancy, but EllaOne has a five-day window
    instead of Plan B's three-day effective
    period. EllaOne received a unanimous
    endorsement by the FDA advisory panel one
    month before its approval.
Gilenya

   Drug: Gilenya (fingolimod)
    Indication: Multiple sclerosis
    Companies: Novartis
    Approval Date: September 21
   Drug type: Small molecule
   Summary: As the first oral MS drug, Novartis
    expects blockbuster results from Gilenya,
    estimating annual sales at up to $3.5 billion in an
    $11 billion-per-year
    market. The immunomodulator's next
    oral competitor is Merck KGaA's cladribine, which
    will be reviewed by Feb. 28.
Halaven

   Drug: Halaven (eribulin mesylate)
    Indication: Breast cancer
    Companies: Eisai
    Approval Date: November 15
   Drug type: Small molecule
   Summary: Just as its Alzheimer's drug Aricept
    was coming off patent, Eisai garnered FDA
    approval for its third-line breast cancer drug,
    Halaven. The microtubule inhibitor injectable is a
    synthetic version of a compound derived from a
    sea sponge. Patients receiving the treatment
    should have gone through two types of
    chemotherapy to combat breast cancer.
Jevtana

   Drug: Jevtana (cabazitaxel)
    Indication: Prostate cancer
    Companies: Sanofi-Aventis
    Approval Date: June 17
   Drug type: Small molecule
   Summary: Sanofi's microtubule inhibitor injection
    was approved by the FDA as a second-line
    treatment for metastatic hormone-refractory
    prostate cancer. The drug is used in conjunction
    with prednisone after patients have undergone
    docetaxel-based chemotherapy.
Krystexxa

   Drug: Krystexxa (pegloticase)
    Indication: Gout
    Companies: Savient Pharmaceuticals
    Approval Date: September 14
   Drug type: Biologics
   Summary: After a year of FDA woes, Savient's
    gout biologic Krystexxa gained approval in
    September. In July 2009, the second-line drug
    was rejected by the FDA over manufacturing
    concerns, which sent Savient's shares spiraling. In
    October, the company hit another snag after it had
    trouble raising the money needed to launch
    Krystexxa.
Lastacaft

   Drug: Lastacaft (alcaftadine ophthalmic
    solution)
    Indication: Itching associated with pink eye
    Companies: Johnson & Johnson, Allergan
    Approval Date: July 28
   Drug type: Small molecule
   Summary: J&J and Allergan's eye solution
    was approved by the FDA for itching
    associated with conjunctivitis in patients older
    than two years. The recommended dosage is
    one drop per eye per day.
Latuda

   Drug: Latuda (lurasidone HCl)
    Indication: Schizophrenia
    Companies: Dainippon Sumitomo
    Approval Date: October 28
   Drug type: Small molecule
   Summary: In October, the FDA approved another
    schizophrenia treatment, Dainippon Sumitomo's
    Latuda. In four six-week studies, the drug
    performed better than a placebo in reducing
    schizophrenic symptoms. Like all other atypical
    antipsychotics, Latuda is not approved for
    treatment of dementia-related psychosis.
Lumizyme

   Drug: Lumizyme (alglucosidase alfa)
    Indication: Pompe disease
    Companies: Genzyme
    Approval Date: May 24
   Drug type: Biologics
   Summary: After two rejections, Genzyme received FDA
    approval for its late-onset Pompe disease drug, Lumizyme.
    The gene mutation causes heart, skeletal and respiratory
    weakness, leading to respiratory failure and death.
    Lumizyme replaces the acid alpha-glucosidase
    (GAA) and reduce glycogen in the heart and muscle. The
    drug was approved with REMS, restricted distribution and a
    warning of anaphylaxis, severe allergic reactions and
    immune-mediated reactions
Natazia

   Drug: Natazia (estradiol valerate and estradiol
    valerate/dienogest)
    Indication: Contraceptive
    Companies: Bayer
    Approval Date: May 7
   Drug type: Small molecule
   Summary: The first four-phasic birth control pill,
    Natazia, was aproved on May 7. Bayer's newest
    female oral contraceptive delivers both estrogen
    and progestin in four varying amounts over the
    28-day cycle
Pradaxa

   Drug: Pradaxa (dabigatran etexilate mesylate)
    Indication: Atrial fibrillation
    Companies: Boehringer Ingelheim
    Approval Date: October 19
   Drug type: Small molecule
   Summary: In the race for the bloodthinner
    warfarin's replacement, Boehringer took an early
    lead with Pradaxa's approval. Analysts believe the
    drug could produce $1.3 billion in revenue per
    year, but its competitors could come along soon:
    namely J&J's Xarelto and the BMS/Pfizer partner
    drug apixaban
Prolia

   Drug: Prolia (denosumab)
    Indication: Osteoporosis
    Companies: Amgen
    Approval Date: June 1
   Drug type: Biologics
   Summary: Only days after receiving European approval, and
    almost two months ahead of schedule, Amgen's
    postmenopausal osteoporosis treatment, Prolia, was
    approved by the FDA. The drug is administered via twice-
    annually injections. "We're not trying to go out there and take
    business away from existing drugs... but we recognize that
    this is a very unsatisfied group of patients that need other
    options," Roger Perlmutter, Amgen's EVP of research and
    development, told the Wall Street Journal.
Teflaro

   Drug: Teflaro (ceftaroline fosamil)
    Indication: Skin infections, bacterial pneumonia
    Companies: Forest Laboratories
    Approval Date: October 29
   Drug type: Small molecule
   Summary: Infection fighters have a new ally in Forest
    Lab's injectable antibiotic Teflaro. The cephalosporin
    was approved to treat community acquired bacterial
    pneumonia (CABP) and acute bacterial skin and skin
    structure infections, including methicillin-resistant
    Staphylococcus aureus (MRSA). Many of these
    serious infections are more common in healthcare
    settings and are resistant to more common antibiotics.
Victoza

   Drug: Victoza (liraglutide)
    Indication: Diabetes
    Companies: Novo Nordisk
    Approval Date: January 25
   Drug type: Small molecule
   Summary: Six after winning approval in Europe, U.S.
    regulators gave the okay to Novo Nordisk's potential
    blockbuster type II diabetes drug Victoza. The drug is an
    improvement over traditional therapies in that tt doesn't risk
    pushing blood sugar too low and promotes weight loss in
    patients. However, the FDA was spooked by animal data that
    demonstrated Victoza was linked to a greater risk of
    tumors, which contributed to a 21-month review process.
    Though Victoza's label will carry a warning for the increased
    risk of thyroid cancer, analysts still expect sales of the drug to
    peak at around $1.33 billion annually
Vpriv

   Drug: Vpriv (velaglucerase alfa)
    Indication: Gaucher disease
    Companies: Shire Pharmaceuticals
    Approval Date: February 26
   Drug type: Small molecule
   Summary: With Genzyme's Gaucher disease drug
    Cerezyme sidelined by manufacturing issues, Shire
    raced to regulators with its own Gaucher's treatment.
    And after winning approval the company set its sights
    on permanently wresting control of the disease market
    from Genzyme. Shire priced Vpriv 15 percent below
    Genzyme's $200,000 asking price for Cerezyme--an
    attractive option for insurers who'd like to save
    $30,000 on treating those with the rare disease
Xeomin

   Drug: Xeomin (incobotulinumtoxinA)
    Indication: Uncontrolled muscle contractions
    Companies: Merz Pharmaceuticals
    Approval Date: July 30
   Drug type: Biologics
   Summary: According to Merz, more than 84,000
    patients have been treated with Xeomin worldwide
    since 2005. And last summer, the U.S. joined 19 other
    countries to have approved the product for the
    treatment of cervical dystonia and blepharospasm.
    Xeomin is the only botulinum toxin that does not
    require refrigeration prior to reconstitution, and Merz
    believes this may simplify product distribution and
    storage and ensure product integrity at the time of
    injection.
Xiaflex

   Drug: Xiaflex (collagenase clostridium histolyticum)
    Indication: Depuytren's contracture
    Companies: Auxilium Pharmaceuticals
    Approval Date: February 2
   Drug type: Biologic
   Summary: Auxilium Pharmaceuticals won the unanimous
    backing of an FDA advisory panel for its experimental therapy
    to treat Dupuytren's contracture back in the fall 2009. Roughly 7
    million to 14 million people suffer from Dupuytren's disease, a
    buildup of collagen that leaves fingers bent with patients unable
    to extend them normally. "We believe the approval of Xiaflex
    represents a major breakthrough for patients suffering from the
    debilitating effects of Dupuytren's contracture," says Auxilium
    CEO Armando Anido. Last winter, Auxilium scored a $15 million
    milestone from Pfizer, which holds the rights to sell the drug in
    Europe.
Glassia - 2010 CBER Approvals
  Drug: Glassia (Alpha1-Proteinase Inhibitor)
 Indication: Treatment of chronic augmentation and
 maintenance therapy in individuals with emphysema due to
 congenital deficiency of alpha-1-proteinase inhibitor
 Company: Kamada
 Approval Date: July 1
 Summary: Glassia is a ready-to-use liquid Alpha- 1-
 Proteinase Inhibitor that is indicated for chronic augmentation
 and maintenance therapy in adults with emphysema due to
 congenital deficiency of alpha1-proteinase inhibitor.
 In August, Baxter International announced a definitive
 agreement with Kamada for exclusive commercial rights to
 the product in the U.S., Australia, New Zealand and Canada
Hizentra - 2010 CBER Approvals
  Drug: Hizentra
 Indication: primary immunodeficiency
 Company: CSL Behring
 Approval Date: March 4
 Summary: As the first FDA-approved 20 percent
 subcutaneous immunoglobulin-- the highest concentration so
 far--Hizentra offers patients with compromised immune
 systems a preventative step and treatment for prevalent
 infections. While intravenous immunoglobulin is still the first-
 line standard of care for many immunodeficient patients,
 CSL's nonrefrigerated therapy is administered weekly via a
 portable pump. Hizentra is considered a replacement for
 CSL's previous 16 percent immunoglobulin drug, Vivaglobin,
 which was the only FDA-approved, self-administered
 treatment.
Menveo - 2010 CBER Approvals
Drug: Menveo (Groups A, C, Y, and W-135)
oligosaccharide diphtheria CRM197 conjugate vaccine
Indication: Immunization to prevent invasive
meningococcal disease caused by Neisseria
meningitidis serogroups A, C, Y and W-135
Company: Novartis
Approval Date: February 19

Summary: FDA approved Novartis' Menveo vaccine
for use in 11-55 year olds to help protect against
meningitis and sepsis caused by four common vaccine-
preventable serogroups. At the time, it was anticipated
that the approval could help Novartis rake in up to $650
million a year.
Prevnar-13 - 2010 CBER
Approvals
    Drug: Prevnar 13 (Pneumococcal 13-valent Conjugate
    Vaccine [Diphtheria CRM197 Protein])
    Indication: The active immunization for the prevention of
    invasive disease caused by 13 serotypes of S. pneumoniae
    Company: Pfizer
    Approval Date: February 24
    Summary: The FDA last February approved Pfizer's
    childhood vaccine Prevnar-13, which significantly expands
    the protection provided by Prevnar 7, a global blockbuster
    with $3 billion in annual sales. Analysts have pegged likely
    sales of Prevnar 13 at about $5 billion in 2014.
   Late last month, Pfizer submitted supplemental applications
    to the FDA and EMA to expand the use of Prevnar 13 to
    adults 50 years of age and older. The applications are based
    on six Phase III studies involving approximately 6,000
    subjects.
Provenge - 2010 CBER
Approvals
 Drug: Provenge
Indication: prostate cancer
Company: Dendreon
Approval Date: April 29
Summary: After a 2007 hurdle, Dendreon received FDA
approval for its prostate cancer vaccine, Provenge, on April
29. And despite the $93,000 price tag for a full three-treatment
course, many analysts consider the vax a future
blockbuster, despite early supply delays that hampered its
sales (the company pulled in $48 million in 2010). In
November, a Centers for Medicare and Medicaid Services
panel approved patient reimbursement for on-label usage of
Provenge, which, for now, points toward more limited
reimbursements when the CMS makes its final decision. With
the new year came new plans as Dendreon turns its focus to
European approval in 2013

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Drugs approved in 2010

  • 2. Ampyra  Drug: Ampyra (dalfampridine) Indication: Multiple sclerosis Companies: Acorda Therapeutics Approval Date: January 22  Drug type: Small molecule  Summary: Acorda's MS drug focused on helping patients' walking difficulties, and according to the company, is the only drug that can increase walking speeds in those affected. The drug's approval sparked almost immediate buyout rumors for Acorda. Although none came to fruition, the company has a manufacturing deal with Elan for the drug.
  • 3. Asclera  Drug: Asclera (polidocanol) Indication: Varicose veins Companies: Chemische Fabrik Kresussler Approval Date: March 30  Drug Type: Small molecule  Summary: The FDA approved Chemische Fabrik Kresussler's drug in March for spider veins (varicose veins smaller than 1 mm in diameter) and reticular veins (those 1 to 3 mm in diameter) in March. The drug attacks the vein's cellular wall lining, causing the vessel to close.
  • 4. Carbaglu  Drug: Carbaglu (carglumic acid) Indication: NAGS deficiency Companies: Orphan Europe Approval Date: March 18  Drug type: Small molecule  Summary: Despite early concerns that study designs could have interfered with drug testing results, the FDA unanimously approved Carbaglu for patients with N-acetylglutamate synthase, or NAGS, deficiency, which causes excess amounts of ammonia in the blood. The drug is a Carbamoyl Phosphate Synthetase 1 activator
  • 5. Egrifta  Drug: Egrifta (tesamorelin) Indication: HIV Companies: Theratechnologies Approval Date: November 10  Drug type: Small molecule  Summary: Egrifta was approved to treat lipodystrophy, a condition common in those taking antiretroviral drugs to treat HIV. Lipodystrophy causes excess fat buildup particularly in the abdominal region. The growth hormone releasing factor (GRF) drug is administered via a daily injection, and was more effective than a placebo injection in clinical trials
  • 6. EllaOne  Drug: EllaOne (ulipristal acetate) Indication: Emergency contraceptive Companies: HRA Pharma, Watson Approval Date: August 13  Drug type: Small molecule  Summary: Billed as the new "morning-after pill," EllaOne. Like Plan B, the pill is taken after intercourse to reduce the risk of pregnancy, but EllaOne has a five-day window instead of Plan B's three-day effective period. EllaOne received a unanimous endorsement by the FDA advisory panel one month before its approval.
  • 7. Gilenya  Drug: Gilenya (fingolimod) Indication: Multiple sclerosis Companies: Novartis Approval Date: September 21  Drug type: Small molecule  Summary: As the first oral MS drug, Novartis expects blockbuster results from Gilenya, estimating annual sales at up to $3.5 billion in an $11 billion-per-year market. The immunomodulator's next oral competitor is Merck KGaA's cladribine, which will be reviewed by Feb. 28.
  • 8. Halaven  Drug: Halaven (eribulin mesylate) Indication: Breast cancer Companies: Eisai Approval Date: November 15  Drug type: Small molecule  Summary: Just as its Alzheimer's drug Aricept was coming off patent, Eisai garnered FDA approval for its third-line breast cancer drug, Halaven. The microtubule inhibitor injectable is a synthetic version of a compound derived from a sea sponge. Patients receiving the treatment should have gone through two types of chemotherapy to combat breast cancer.
  • 9. Jevtana  Drug: Jevtana (cabazitaxel) Indication: Prostate cancer Companies: Sanofi-Aventis Approval Date: June 17  Drug type: Small molecule  Summary: Sanofi's microtubule inhibitor injection was approved by the FDA as a second-line treatment for metastatic hormone-refractory prostate cancer. The drug is used in conjunction with prednisone after patients have undergone docetaxel-based chemotherapy.
  • 10. Krystexxa  Drug: Krystexxa (pegloticase) Indication: Gout Companies: Savient Pharmaceuticals Approval Date: September 14  Drug type: Biologics  Summary: After a year of FDA woes, Savient's gout biologic Krystexxa gained approval in September. In July 2009, the second-line drug was rejected by the FDA over manufacturing concerns, which sent Savient's shares spiraling. In October, the company hit another snag after it had trouble raising the money needed to launch Krystexxa.
  • 11. Lastacaft  Drug: Lastacaft (alcaftadine ophthalmic solution) Indication: Itching associated with pink eye Companies: Johnson & Johnson, Allergan Approval Date: July 28  Drug type: Small molecule  Summary: J&J and Allergan's eye solution was approved by the FDA for itching associated with conjunctivitis in patients older than two years. The recommended dosage is one drop per eye per day.
  • 12. Latuda  Drug: Latuda (lurasidone HCl) Indication: Schizophrenia Companies: Dainippon Sumitomo Approval Date: October 28  Drug type: Small molecule  Summary: In October, the FDA approved another schizophrenia treatment, Dainippon Sumitomo's Latuda. In four six-week studies, the drug performed better than a placebo in reducing schizophrenic symptoms. Like all other atypical antipsychotics, Latuda is not approved for treatment of dementia-related psychosis.
  • 13. Lumizyme  Drug: Lumizyme (alglucosidase alfa) Indication: Pompe disease Companies: Genzyme Approval Date: May 24  Drug type: Biologics  Summary: After two rejections, Genzyme received FDA approval for its late-onset Pompe disease drug, Lumizyme. The gene mutation causes heart, skeletal and respiratory weakness, leading to respiratory failure and death. Lumizyme replaces the acid alpha-glucosidase (GAA) and reduce glycogen in the heart and muscle. The drug was approved with REMS, restricted distribution and a warning of anaphylaxis, severe allergic reactions and immune-mediated reactions
  • 14. Natazia  Drug: Natazia (estradiol valerate and estradiol valerate/dienogest) Indication: Contraceptive Companies: Bayer Approval Date: May 7  Drug type: Small molecule  Summary: The first four-phasic birth control pill, Natazia, was aproved on May 7. Bayer's newest female oral contraceptive delivers both estrogen and progestin in four varying amounts over the 28-day cycle
  • 15. Pradaxa  Drug: Pradaxa (dabigatran etexilate mesylate) Indication: Atrial fibrillation Companies: Boehringer Ingelheim Approval Date: October 19  Drug type: Small molecule  Summary: In the race for the bloodthinner warfarin's replacement, Boehringer took an early lead with Pradaxa's approval. Analysts believe the drug could produce $1.3 billion in revenue per year, but its competitors could come along soon: namely J&J's Xarelto and the BMS/Pfizer partner drug apixaban
  • 16. Prolia  Drug: Prolia (denosumab) Indication: Osteoporosis Companies: Amgen Approval Date: June 1  Drug type: Biologics  Summary: Only days after receiving European approval, and almost two months ahead of schedule, Amgen's postmenopausal osteoporosis treatment, Prolia, was approved by the FDA. The drug is administered via twice- annually injections. "We're not trying to go out there and take business away from existing drugs... but we recognize that this is a very unsatisfied group of patients that need other options," Roger Perlmutter, Amgen's EVP of research and development, told the Wall Street Journal.
  • 17. Teflaro  Drug: Teflaro (ceftaroline fosamil) Indication: Skin infections, bacterial pneumonia Companies: Forest Laboratories Approval Date: October 29  Drug type: Small molecule  Summary: Infection fighters have a new ally in Forest Lab's injectable antibiotic Teflaro. The cephalosporin was approved to treat community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus (MRSA). Many of these serious infections are more common in healthcare settings and are resistant to more common antibiotics.
  • 18. Victoza  Drug: Victoza (liraglutide) Indication: Diabetes Companies: Novo Nordisk Approval Date: January 25  Drug type: Small molecule  Summary: Six after winning approval in Europe, U.S. regulators gave the okay to Novo Nordisk's potential blockbuster type II diabetes drug Victoza. The drug is an improvement over traditional therapies in that tt doesn't risk pushing blood sugar too low and promotes weight loss in patients. However, the FDA was spooked by animal data that demonstrated Victoza was linked to a greater risk of tumors, which contributed to a 21-month review process. Though Victoza's label will carry a warning for the increased risk of thyroid cancer, analysts still expect sales of the drug to peak at around $1.33 billion annually
  • 19. Vpriv  Drug: Vpriv (velaglucerase alfa) Indication: Gaucher disease Companies: Shire Pharmaceuticals Approval Date: February 26  Drug type: Small molecule  Summary: With Genzyme's Gaucher disease drug Cerezyme sidelined by manufacturing issues, Shire raced to regulators with its own Gaucher's treatment. And after winning approval the company set its sights on permanently wresting control of the disease market from Genzyme. Shire priced Vpriv 15 percent below Genzyme's $200,000 asking price for Cerezyme--an attractive option for insurers who'd like to save $30,000 on treating those with the rare disease
  • 20. Xeomin  Drug: Xeomin (incobotulinumtoxinA) Indication: Uncontrolled muscle contractions Companies: Merz Pharmaceuticals Approval Date: July 30  Drug type: Biologics  Summary: According to Merz, more than 84,000 patients have been treated with Xeomin worldwide since 2005. And last summer, the U.S. joined 19 other countries to have approved the product for the treatment of cervical dystonia and blepharospasm. Xeomin is the only botulinum toxin that does not require refrigeration prior to reconstitution, and Merz believes this may simplify product distribution and storage and ensure product integrity at the time of injection.
  • 21. Xiaflex  Drug: Xiaflex (collagenase clostridium histolyticum) Indication: Depuytren's contracture Companies: Auxilium Pharmaceuticals Approval Date: February 2  Drug type: Biologic  Summary: Auxilium Pharmaceuticals won the unanimous backing of an FDA advisory panel for its experimental therapy to treat Dupuytren's contracture back in the fall 2009. Roughly 7 million to 14 million people suffer from Dupuytren's disease, a buildup of collagen that leaves fingers bent with patients unable to extend them normally. "We believe the approval of Xiaflex represents a major breakthrough for patients suffering from the debilitating effects of Dupuytren's contracture," says Auxilium CEO Armando Anido. Last winter, Auxilium scored a $15 million milestone from Pfizer, which holds the rights to sell the drug in Europe.
  • 22. Glassia - 2010 CBER Approvals Drug: Glassia (Alpha1-Proteinase Inhibitor) Indication: Treatment of chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor Company: Kamada Approval Date: July 1 Summary: Glassia is a ready-to-use liquid Alpha- 1- Proteinase Inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor. In August, Baxter International announced a definitive agreement with Kamada for exclusive commercial rights to the product in the U.S., Australia, New Zealand and Canada
  • 23. Hizentra - 2010 CBER Approvals Drug: Hizentra Indication: primary immunodeficiency Company: CSL Behring Approval Date: March 4 Summary: As the first FDA-approved 20 percent subcutaneous immunoglobulin-- the highest concentration so far--Hizentra offers patients with compromised immune systems a preventative step and treatment for prevalent infections. While intravenous immunoglobulin is still the first- line standard of care for many immunodeficient patients, CSL's nonrefrigerated therapy is administered weekly via a portable pump. Hizentra is considered a replacement for CSL's previous 16 percent immunoglobulin drug, Vivaglobin, which was the only FDA-approved, self-administered treatment.
  • 24. Menveo - 2010 CBER Approvals Drug: Menveo (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine Indication: Immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Company: Novartis Approval Date: February 19 Summary: FDA approved Novartis' Menveo vaccine for use in 11-55 year olds to help protect against meningitis and sepsis caused by four common vaccine- preventable serogroups. At the time, it was anticipated that the approval could help Novartis rake in up to $650 million a year.
  • 25. Prevnar-13 - 2010 CBER Approvals Drug: Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Indication: The active immunization for the prevention of invasive disease caused by 13 serotypes of S. pneumoniae Company: Pfizer Approval Date: February 24 Summary: The FDA last February approved Pfizer's childhood vaccine Prevnar-13, which significantly expands the protection provided by Prevnar 7, a global blockbuster with $3 billion in annual sales. Analysts have pegged likely sales of Prevnar 13 at about $5 billion in 2014.  Late last month, Pfizer submitted supplemental applications to the FDA and EMA to expand the use of Prevnar 13 to adults 50 years of age and older. The applications are based on six Phase III studies involving approximately 6,000 subjects.
  • 26. Provenge - 2010 CBER Approvals Drug: Provenge Indication: prostate cancer Company: Dendreon Approval Date: April 29 Summary: After a 2007 hurdle, Dendreon received FDA approval for its prostate cancer vaccine, Provenge, on April 29. And despite the $93,000 price tag for a full three-treatment course, many analysts consider the vax a future blockbuster, despite early supply delays that hampered its sales (the company pulled in $48 million in 2010). In November, a Centers for Medicare and Medicaid Services panel approved patient reimbursement for on-label usage of Provenge, which, for now, points toward more limited reimbursements when the CMS makes its final decision. With the new year came new plans as Dendreon turns its focus to European approval in 2013