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New Drug Approvals 2011
(fiscal year ending Sep 2011)




        Compiled by: Naveen Kumar
Introduction
• Over the past 12 months, the U.S.
  Food and Drug Administration
  approved 35 new medicines
• Highest number of approvals in the
  past decade, surpassed only by
  2009 (37)
• FDA approved 24 – almost 70% – of
  the 35 new drugs before any other
  country in the world
• There were breakthroughs in
  personalized medicine: two of the
  drugs, for lung cancer and melanoma
• Ten of the approved treatments are
  for rare or ―orphan‖ diseases, which
  have few or no drug treatment
  options because of their small patient
  populations (less than 200,000)
NMEs approved last decade
     Calender year   NMEs Approved
         2001             24
         2002             17
         2003             21
         2004             36
         2005             20
         2006             22
         2007             18
         2008             24
         2009             26
         2010             21
         2011             35
I. Priority Drugs
Drug name       Approval   Indication                    sponsor
                date
Caprelsa        6/4/11     To treat adult patients with   AZ
(vandetanib)               metastatic (late stage)
                           medullary thyroid cancer
                           who are ineligible for surgery
                           and who have disease that
                           is growing or causing
                           symptoms
Cortifact       17/2/11    For routine prophylactic      CSL Bhering
(Factor XIII               treatment of congenital       GmbH,
concentrate                factor XIII deficiency        King of Prussia,
[Human} )                                                PA
DaTscan         14/1/11    For brain imaging to assist in GE Healthcare
(ioflupane i-              the evaluation of adult
123)                       patients with suspected
                           Parkinsonian Syndrome
I. Priority Drugs (Contd.)
Drug name       Approval   Indication             Sponsor
                date
Dificid         27/5/11    For treatment of       Optimer
(fidaxomicin)              Clostridium            Pharmaceuticals
                           difficile-associated
                           diarrhea (CDAD)
Firazyr         25/8/11    For treatment of        Shire Human
(icatibant)                acute attacks of        Genetic Therapies
                           a rare condition called
                           hereditary
                           angioedema (HAE)
                           in people ages 18
                           years and older
Halaven         15/11/10   For treatment of     Eisai
(eribulin                  patients with
mesylate)                  metastatic (late-
                           stage) breast cancer
I. Priority Drugs (Contd.)
Drug name      Approval   Indication                      Sponsor
               date
Incivek        23/5/11    For treatment of certain        Vertex
(telaprevir)              adults with chronic             Pharmaceuticals
                          hepatitis C infection


Pradaxa        19/10/10   To reduce the risk of           Boehringer
(dabigatran               stroke and blood clots in       Ingelheim Pharm
etexilate)                patients with abnormal
                          heart rhythms (non-
                          valvular atrial fibrillation)


Victrelis      13/5/11    To treat certain adults         Merck
(boceprevir)              with chronic
                          hepatitis C infection
I. Priority Drugs (Contd.)
Drug name           Approval   Indication                       sponsor
                    date
Adcetris            19/8/11    For treatment of Hodgkin’s       Seattle
(brentuximab                   lymphoma and ALCL                Genetics
vedotin)                       (systemic anaplastic             Bothell
                               large cell lymphoma)
Anascorp            3/8/11     For treatment of clinical        Rare
(Centruroides                  signs of scorpion                Disease
[Scorpion]                     envenomation                     Therapeutics
Immune
F(ab’)2 [Equine])
Benlysta            9/3/11     To treat patients with active,   Human
(belimumab)                    autoantibody-positive lupus      Genome
                               (systemic lupus                  Sciences
                               erythematosus) who are
                               receiving standard therapy
I. Priority Drugs (Contd.)
Drug name      Approval   Indication                       Sponsor
               date

Xalkori        26/8/11    To treat certain patients with   Pfizer
(crizotinib)              late stage (locally advanced
                          or metastatic), non-small cell
                          lung cancers (NSCLC) who
                          express the abnormal
                          anaplastic lymphoma
                          kinase (ALK) gene




Yervoy         25/3/11    To treat patients with           BMS
(ipilimumab)              metastatic melanoma (late-
                          stage skin cancer)
I. Priority Drugs (Contd.)
Drug name        Approval   Indication                       sponsor
                 date
Zelboraf         17/8/11    To treat patients with           Genetech
(vemuranfenib)              metastatic (late-stage) or
with companion              unresected (cannot
diagnostic                  be removed by surgery)
                            melanoma (skin cancer) in
                            patients whose tumors
                            express a gene mutation
                            called BRAF V600E
Zytiga           28/4/11    To use In combination with       Centocor
(albiraterone               prednisone (a steroid), to       Ortho
acetate)                    treat patients with metastatic   Biotech
                            (late-stage) castration-
                            resistant prostate cancer
                            who have received prior
                            docetaxel (chemotherapy)
II. Standard drugs
Drug name      Approval   Indication                      sponsor
               date
Arcapta        1/7/11     For long term, once-daily       Novartis
Neohaler                  maintenance bronchodilator
(indacaterol              treatment of airflow
inhalation                obstruction in people with
powder)                   chronic obstructive pulmonary
                          disease (COPD) including
                          chronic bronchitis and/or
                          emphysema
Ardovax        16/3/11    For active immunization for     Teva
(Adenovirus               the prevention of febrile       Women’s
Type 4                    acute respiratory disease       Health
and Type 7                caused by Adenovirus Type
Vaccine,                  4 and Type 7
Live, Oral)
II. Standard drugs(Contd.)
Drug name       Approval   Indication                     Sponsor
                date
Brilinta        20/7/11    To reduce cardiovascular       AZ
(ticagrelor)               death and heart attack in
                           patients with acute
                           coronary syndromes (ACS)

Daliresp        28/2/11    To decrease the frequency of   Forest
(roflumilast)              flare-ups (exacerbations) or
                           worsening of symptoms from
                           severe chronic
                           obstructive pulmonary
                           disease (COPD)

Edarbi          25/2/11    For treatment of high blood    Takeda
azilsartan                 pressure (hypertension) in
medoxomil)                 adults
II. Standard drugs(Contd.)
Drug name       Approval   Indication                     sponsor
                date
Edurant         20/5/11    For treatment of HIV-1         Tibotec
(rilpivirine)              infection in adults who have   Therapeut
                           never taken HIV therapy        ics
Egrifta         10/11/10   For reduction of excess        Theratech
(tesamorelin               abdominal fat in HIV-          nologies
acetate)                   infected patients with
                           lipodystrophy
Gadavist        14/3/11    Contrast agent to help detect Bayer
(gadobutrol)               lesions in patients undergoing
                           magnetic resonance imaging
                           (MRI) of the central nervous
                           system
Horizant        6/4/11     For once-daily treatment for   GSK and
(gabapentin                moderate-to-severe restless    Xenoport
enacarbil)                 legs syndrome (RLS)
II. Standard drugs(Contd.)
Drug name        Approval   Indication                      sponsor
                 date
Latuda           28/10/10   For treatment of                Sunovian
(lurasidone                 schizophrenia in                Pharm
hydrochloride)              adults
LaViv            21/6/11    For improvement of the          Fibrocell
(Azficel-T)                 appearance of moderate to
                            severe nasolabial fold
                            wrinkles in adults
Natroba          18/1/11    For treatment of head lice      ParaPRO
(spinosad)                  infestation in patients ages
                            4 years and older
Nulojix          15/6/11    To prevent organ rejection in   BMS
(belatacept)                adult patients who have had
                            a kidney transplant, in
                            combination with other
                            immunosuppressants
II. Standard drugs(Contd.)
Drug name      Approval   Indication                sponsor
               date
Potiga         10/6/11    For use as an add-on      Valeant pharm,
(ezogabine)               medication to treat       mktd by GSK
                          seizures associated
                          with epilepsy in adults
Spherusol      29/7/11    For detection of        Allermed
                          delayed type            Laboratories
                          hypersensitivity to C.
                          immitis in individuals,
                          18-64 years of age
Teflaro        29/10/10   For treatment of acute    Cerexa
(ceftaroline              bacterial skin and skin
fosamil)                  structure infections
                          and community
                          acquired bacterial
                          pneumonia
II. Standard drugs(Contd.)
Drug name        Approval Indication                    sponsor
                 date
Tradjenta        2/5/11    For use as an adjunct to     Boehringer
(linagliptin)              diet and exercise to         Ingelheim,
                           improve glycemic             Eli Lilly
                           (blood sugar) control in
                           adults with type 2
                           diabetes.
Viibryd          21/1/11   For treatment of major       PGx Health
(vilazodone                depressive disorder in
hydrochloride)             adults.
Xarelto          1/7/11    To reduce the risk of        Janssen
(rivaroxaban)              blood clots, deep vein       Pharma-
                           thrombosis (DVT), and        ceuticals,
                           pulmonary embolism           Bayer
                           (PE) following knee or hip
                           replacement surgery
Orphan drugs approved
1. Adcetris
2. Anascorp
3. Caprelsa
4. Corifact
5. Firazyr
6. Xalkori
7. Yervoy
8. Zelboraf
9. Nulojix
10.Spherusol
Drugs approved for
cancer treatment
1.   Zytiga
2.   Zelboraf
3.   Xalkori
4.   Yervoy
5.   Adcetris
6.   Caprelsa
7.   Halaven
2011 approvals summary
• Of the drugs approved in 2011, many
  included new advances for critically ill
  patients such as two new treatments for
  hepatitis C, a drug for late-stage prostate
  cancer and the first new drug for Hodgkin's
  lymphoma in 30 years
• first new drug for lupus in 50 years
• 34 of the 35 drugs were approved before or
  on the review time targets, including three
  cancer drugs that received FDA approval in
  less than six months.
Contd…
• 2 of the drugs—1 for melanoma and 1 for
  lung cancer—represent breakthroughs in
  personalized medicine
• 7 of the new medicines provide major
  advances in cancer treatment
• Almost half of the drugs were deemed to
  be significant therapeutic advances over
  existing therapies for heart attack, stroke,
  and kidney transplant rejection
• 10 are indicated for orphan diseases,
  which frequently lack any therapy
Contd…
• 16 were approved under priority
  review, in which the FDA has a 6-
  month goal to complete its review for
  safety and effectiveness
• Two-thirds of the new approvals were
  completed in a single review cycle
• 3 were approved using ―accelerated
  approval,‖ including Corifact, the first
  treatment approved for a rare blood
  clotting disorder.

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New drug approvals 2011

  • 1. New Drug Approvals 2011 (fiscal year ending Sep 2011) Compiled by: Naveen Kumar
  • 2. Introduction • Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines • Highest number of approvals in the past decade, surpassed only by 2009 (37) • FDA approved 24 – almost 70% – of the 35 new drugs before any other country in the world
  • 3. • There were breakthroughs in personalized medicine: two of the drugs, for lung cancer and melanoma • Ten of the approved treatments are for rare or ―orphan‖ diseases, which have few or no drug treatment options because of their small patient populations (less than 200,000)
  • 4. NMEs approved last decade Calender year NMEs Approved 2001 24 2002 17 2003 21 2004 36 2005 20 2006 22 2007 18 2008 24 2009 26 2010 21 2011 35
  • 5.
  • 6. I. Priority Drugs Drug name Approval Indication sponsor date Caprelsa 6/4/11 To treat adult patients with AZ (vandetanib) metastatic (late stage) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms Cortifact 17/2/11 For routine prophylactic CSL Bhering (Factor XIII treatment of congenital GmbH, concentrate factor XIII deficiency King of Prussia, [Human} ) PA DaTscan 14/1/11 For brain imaging to assist in GE Healthcare (ioflupane i- the evaluation of adult 123) patients with suspected Parkinsonian Syndrome
  • 7. I. Priority Drugs (Contd.) Drug name Approval Indication Sponsor date Dificid 27/5/11 For treatment of Optimer (fidaxomicin) Clostridium Pharmaceuticals difficile-associated diarrhea (CDAD) Firazyr 25/8/11 For treatment of Shire Human (icatibant) acute attacks of Genetic Therapies a rare condition called hereditary angioedema (HAE) in people ages 18 years and older Halaven 15/11/10 For treatment of Eisai (eribulin patients with mesylate) metastatic (late- stage) breast cancer
  • 8. I. Priority Drugs (Contd.) Drug name Approval Indication Sponsor date Incivek 23/5/11 For treatment of certain Vertex (telaprevir) adults with chronic Pharmaceuticals hepatitis C infection Pradaxa 19/10/10 To reduce the risk of Boehringer (dabigatran stroke and blood clots in Ingelheim Pharm etexilate) patients with abnormal heart rhythms (non- valvular atrial fibrillation) Victrelis 13/5/11 To treat certain adults Merck (boceprevir) with chronic hepatitis C infection
  • 9. I. Priority Drugs (Contd.) Drug name Approval Indication sponsor date Adcetris 19/8/11 For treatment of Hodgkin’s Seattle (brentuximab lymphoma and ALCL Genetics vedotin) (systemic anaplastic Bothell large cell lymphoma) Anascorp 3/8/11 For treatment of clinical Rare (Centruroides signs of scorpion Disease [Scorpion] envenomation Therapeutics Immune F(ab’)2 [Equine]) Benlysta 9/3/11 To treat patients with active, Human (belimumab) autoantibody-positive lupus Genome (systemic lupus Sciences erythematosus) who are receiving standard therapy
  • 10. I. Priority Drugs (Contd.) Drug name Approval Indication Sponsor date Xalkori 26/8/11 To treat certain patients with Pfizer (crizotinib) late stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene Yervoy 25/3/11 To treat patients with BMS (ipilimumab) metastatic melanoma (late- stage skin cancer)
  • 11. I. Priority Drugs (Contd.) Drug name Approval Indication sponsor date Zelboraf 17/8/11 To treat patients with Genetech (vemuranfenib) metastatic (late-stage) or with companion unresected (cannot diagnostic be removed by surgery) melanoma (skin cancer) in patients whose tumors express a gene mutation called BRAF V600E Zytiga 28/4/11 To use In combination with Centocor (albiraterone prednisone (a steroid), to Ortho acetate) treat patients with metastatic Biotech (late-stage) castration- resistant prostate cancer who have received prior docetaxel (chemotherapy)
  • 12. II. Standard drugs Drug name Approval Indication sponsor date Arcapta 1/7/11 For long term, once-daily Novartis Neohaler maintenance bronchodilator (indacaterol treatment of airflow inhalation obstruction in people with powder) chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema Ardovax 16/3/11 For active immunization for Teva (Adenovirus the prevention of febrile Women’s Type 4 acute respiratory disease Health and Type 7 caused by Adenovirus Type Vaccine, 4 and Type 7 Live, Oral)
  • 13. II. Standard drugs(Contd.) Drug name Approval Indication Sponsor date Brilinta 20/7/11 To reduce cardiovascular AZ (ticagrelor) death and heart attack in patients with acute coronary syndromes (ACS) Daliresp 28/2/11 To decrease the frequency of Forest (roflumilast) flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD) Edarbi 25/2/11 For treatment of high blood Takeda azilsartan pressure (hypertension) in medoxomil) adults
  • 14. II. Standard drugs(Contd.) Drug name Approval Indication sponsor date Edurant 20/5/11 For treatment of HIV-1 Tibotec (rilpivirine) infection in adults who have Therapeut never taken HIV therapy ics Egrifta 10/11/10 For reduction of excess Theratech (tesamorelin abdominal fat in HIV- nologies acetate) infected patients with lipodystrophy Gadavist 14/3/11 Contrast agent to help detect Bayer (gadobutrol) lesions in patients undergoing magnetic resonance imaging (MRI) of the central nervous system Horizant 6/4/11 For once-daily treatment for GSK and (gabapentin moderate-to-severe restless Xenoport enacarbil) legs syndrome (RLS)
  • 15. II. Standard drugs(Contd.) Drug name Approval Indication sponsor date Latuda 28/10/10 For treatment of Sunovian (lurasidone schizophrenia in Pharm hydrochloride) adults LaViv 21/6/11 For improvement of the Fibrocell (Azficel-T) appearance of moderate to severe nasolabial fold wrinkles in adults Natroba 18/1/11 For treatment of head lice ParaPRO (spinosad) infestation in patients ages 4 years and older Nulojix 15/6/11 To prevent organ rejection in BMS (belatacept) adult patients who have had a kidney transplant, in combination with other immunosuppressants
  • 16. II. Standard drugs(Contd.) Drug name Approval Indication sponsor date Potiga 10/6/11 For use as an add-on Valeant pharm, (ezogabine) medication to treat mktd by GSK seizures associated with epilepsy in adults Spherusol 29/7/11 For detection of Allermed delayed type Laboratories hypersensitivity to C. immitis in individuals, 18-64 years of age Teflaro 29/10/10 For treatment of acute Cerexa (ceftaroline bacterial skin and skin fosamil) structure infections and community acquired bacterial pneumonia
  • 17. II. Standard drugs(Contd.) Drug name Approval Indication sponsor date Tradjenta 2/5/11 For use as an adjunct to Boehringer (linagliptin) diet and exercise to Ingelheim, improve glycemic Eli Lilly (blood sugar) control in adults with type 2 diabetes. Viibryd 21/1/11 For treatment of major PGx Health (vilazodone depressive disorder in hydrochloride) adults. Xarelto 1/7/11 To reduce the risk of Janssen (rivaroxaban) blood clots, deep vein Pharma- thrombosis (DVT), and ceuticals, pulmonary embolism Bayer (PE) following knee or hip replacement surgery
  • 18. Orphan drugs approved 1. Adcetris 2. Anascorp 3. Caprelsa 4. Corifact 5. Firazyr 6. Xalkori 7. Yervoy 8. Zelboraf 9. Nulojix 10.Spherusol
  • 19. Drugs approved for cancer treatment 1. Zytiga 2. Zelboraf 3. Xalkori 4. Yervoy 5. Adcetris 6. Caprelsa 7. Halaven
  • 20. 2011 approvals summary • Of the drugs approved in 2011, many included new advances for critically ill patients such as two new treatments for hepatitis C, a drug for late-stage prostate cancer and the first new drug for Hodgkin's lymphoma in 30 years • first new drug for lupus in 50 years • 34 of the 35 drugs were approved before or on the review time targets, including three cancer drugs that received FDA approval in less than six months.
  • 21. Contd… • 2 of the drugs—1 for melanoma and 1 for lung cancer—represent breakthroughs in personalized medicine • 7 of the new medicines provide major advances in cancer treatment • Almost half of the drugs were deemed to be significant therapeutic advances over existing therapies for heart attack, stroke, and kidney transplant rejection • 10 are indicated for orphan diseases, which frequently lack any therapy
  • 22. Contd… • 16 were approved under priority review, in which the FDA has a 6- month goal to complete its review for safety and effectiveness • Two-thirds of the new approvals were completed in a single review cycle • 3 were approved using ―accelerated approval,‖ including Corifact, the first treatment approved for a rare blood clotting disorder.