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New drug approvals 2011

New drug approvals 2011



A look at the drugs approved by FDA during the fiscal year 2011 ending sep 2011.

A look at the drugs approved by FDA during the fiscal year 2011 ending sep 2011.



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    New drug approvals 2011 New drug approvals 2011 Presentation Transcript

    • 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 DrugsDrug name Approval Indication sponsor dateCaprelsa 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 symptomsCortifact 17/2/11 For routine prophylactic CSL Bhering(Factor XIII treatment of congenital GmbH,concentrate factor XIII deficiency King of Prussia,[Human} ) PADaTscan 14/1/11 For brain imaging to assist in GE Healthcare(ioflupane i- the evaluation of adult123) patients with suspected Parkinsonian Syndrome
    • I. Priority Drugs (Contd.)Drug name Approval Indication Sponsor dateDificid 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 olderHalaven 15/11/10 For treatment of Eisai(eribulin patients withmesylate) metastatic (late- stage) breast cancer
    • I. Priority Drugs (Contd.)Drug name Approval Indication Sponsor dateIncivek 23/5/11 For treatment of certain Vertex(telaprevir) adults with chronic Pharmaceuticals hepatitis C infectionPradaxa 19/10/10 To reduce the risk of Boehringer(dabigatran stroke and blood clots in Ingelheim Pharmetexilate) 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 dateAdcetris 19/8/11 For treatment of Hodgkin’s Seattle(brentuximab lymphoma and ALCL Geneticsvedotin) (systemic anaplastic Bothell large cell lymphoma)Anascorp 3/8/11 For treatment of clinical Rare(Centruroides signs of scorpion Disease[Scorpion] envenomation TherapeuticsImmuneF(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 dateXalkori 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) geneYervoy 25/3/11 To treat patients with BMS(ipilimumab) metastatic melanoma (late- stage skin cancer)
    • I. Priority Drugs (Contd.)Drug name Approval Indication sponsor dateZelboraf 17/8/11 To treat patients with Genetech(vemuranfenib) metastatic (late-stage) orwith companion unresected (cannotdiagnostic be removed by surgery) melanoma (skin cancer) in patients whose tumors express a gene mutation called BRAF V600EZytiga 28/4/11 To use In combination with Centocor(albiraterone prednisone (a steroid), to Orthoacetate) treat patients with metastatic Biotech (late-stage) castration- resistant prostate cancer who have received prior docetaxel (chemotherapy)
    • II. Standard drugsDrug name Approval Indication sponsor dateArcapta 1/7/11 For long term, once-daily NovartisNeohaler maintenance bronchodilator(indacaterol treatment of airflowinhalation obstruction in people withpowder) chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysemaArdovax 16/3/11 For active immunization for Teva(Adenovirus the prevention of febrile Women’sType 4 acute respiratory disease Healthand Type 7 caused by Adenovirus TypeVaccine, 4 and Type 7Live, Oral)
    • II. Standard drugs(Contd.)Drug name Approval Indication Sponsor dateBrilinta 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 Takedaazilsartan pressure (hypertension) inmedoxomil) adults
    • II. Standard drugs(Contd.)Drug name Approval Indication sponsor dateEdurant 20/5/11 For treatment of HIV-1 Tibotec(rilpivirine) infection in adults who have Therapeut never taken HIV therapy icsEgrifta 10/11/10 For reduction of excess Theratech(tesamorelin abdominal fat in HIV- nologiesacetate) infected patients with lipodystrophyGadavist 14/3/11 Contrast agent to help detect Bayer(gadobutrol) lesions in patients undergoing magnetic resonance imaging (MRI) of the central nervous systemHorizant 6/4/11 For once-daily treatment for GSK and(gabapentin moderate-to-severe restless Xenoportenacarbil) legs syndrome (RLS)
    • II. Standard drugs(Contd.)Drug name Approval Indication sponsor dateLatuda 28/10/10 For treatment of Sunovian(lurasidone schizophrenia in Pharmhydrochloride) adultsLaViv 21/6/11 For improvement of the Fibrocell(Azficel-T) appearance of moderate to severe nasolabial fold wrinkles in adultsNatroba 18/1/11 For treatment of head lice ParaPRO(spinosad) infestation in patients ages 4 years and olderNulojix 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 datePotiga 10/6/11 For use as an add-on Valeant pharm,(ezogabine) medication to treat mktd by GSK seizures associated with epilepsy in adultsSpherusol 29/7/11 For detection of Allermed delayed type Laboratories hypersensitivity to C. immitis in individuals, 18-64 years of ageTeflaro 29/10/10 For treatment of acute Cerexa(ceftaroline bacterial skin and skinfosamil) structure infections and community acquired bacterial pneumonia
    • II. Standard drugs(Contd.)Drug name Approval Indication sponsor dateTradjenta 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 inhydrochloride) 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 approved1. Adcetris2. Anascorp3. Caprelsa4. Corifact5. Firazyr6. Xalkori7. Yervoy8. Zelboraf9. Nulojix10.Spherusol
    • Drugs approved forcancer treatment1. Zytiga2. Zelboraf3. Xalkori4. Yervoy5. Adcetris6. Caprelsa7. 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 Hodgkins 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.