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 2001 2002 2003 NMEs Approved 24 17 21

2004
2005 2006 2007 2008 2009 2010 2011

36
20 22 18 24 26 21 35

I. Priority Drugs
Drug name Caprelsa (vandetanib) Approval date 6/4/11 Indication sponsor To treat adult patients with AZ metastatic (late stage) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms For routine prophylactic treatment of congenital factor XIII deficiency CSL Bhering GmbH, King of Prussia, PA

Cortifact (Factor XIII concentrate [Human} ) DaTscan (ioflupane i123)

17/2/11

14/1/11

For brain imaging to assist in GE Healthcare the evaluation of adult patients with suspected Parkinsonian Syndrome

I. Priority Drugs (Contd.)

Drug name Dificid (fidaxomicin) Approval date 27/5/11 Indication For treatment of Clostridium difficile-associated diarrhea (CDAD) Sponsor Optimer Pharmaceuticals

Firazyr (icatibant)

25/8/11

For treatment of Shire Human acute attacks of Genetic Therapies a rare condition called hereditary angioedema (HAE) in people ages 18 years and older
For treatment of Eisai patients with metastatic (latestage) breast cancer

Halaven (eribulin mesylate)

15/11/10

I. Priority Drugs (Contd.)

Drug name Incivek (telaprevir) Approval date 23/5/11 Indication For treatment of certain adults with chronic hepatitis C infection To reduce the risk of stroke and blood clots in patients with abnormal heart rhythms (nonvalvular atrial fibrillation) Sponsor Vertex Pharmaceuticals

Pradaxa (dabigatran etexilate)

19/10/10

Boehringer Ingelheim Pharm

Victrelis (boceprevir)

13/5/11

To treat certain adults with chronic hepatitis C infection

Merck

I. Priority Drugs (Contd.)

Drug name Adcetris (brentuximab vedotin) Approval date 19/8/11 Indication For treatment of Hodgkins lymphoma and ALCL (systemic anaplastic large cell lymphoma) sponsor Seattle Genetics Bothell

Anascorp (Centruroides [Scorpion] Immune F(ab)2 [Equine]) Benlysta (belimumab)

3/8/11

For treatment of clinical signs of scorpion envenomation

Rare Disease Therapeutics

9/3/11

To treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy

Human Genome Sciences

I. Priority Drugs (Contd.)

Drug name Approval date 26/8/11 Indication Sponsor

Xalkori (crizotinib)

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

Pfizer

Yervoy (ipilimumab)

25/3/11

To treat patients with metastatic melanoma (latestage skin cancer)

BMS

I. Priority Drugs (Contd.)

Drug name Zelboraf (vemuranfenib) with companion diagnostic Approval date 17/8/11 Indication To treat patients with metastatic (late-stage) or unresected (cannot be removed by surgery) melanoma (skin cancer) in patients whose tumors express a gene mutation called BRAF V600E To use In combination with prednisone (a steroid), to treat patients with metastatic (late-stage) castrationresistant prostate cancer who have received prior docetaxel (chemotherapy) sponsor Genetech

Zytiga (albiraterone acetate)

28/4/11

Centocor Ortho Biotech

II. Standard drugs

Drug name Arcapta Neohaler (indacaterol inhalation powder) Approval date 1/7/11 Indication For long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema For active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7 sponsor Novartis

Ardovax (Adenovirus Type 4 and Type 7 Vaccine, Live, Oral)

16/3/11

Teva Womens Health

II. Standard drugs(Contd.)

Drug name Brilinta (ticagrelor) Approval date 20/7/11 Indication To reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS) To decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD) For treatment of high blood pressure (hypertension) in adults Sponsor AZ

Daliresp (roflumilast)

28/2/11

Forest

Edarbi azilsartan medoxomil)

25/2/11

Takeda

II. Standard drugs(Contd.)

Drug name Edurant (rilpivirine) Egrifta (tesamorelin acetate) Gadavist (gadobutrol) Approval date 20/5/11 Indication For treatment of HIV-1 infection in adults who have never taken HIV therapy For reduction of excess abdominal fat in HIVinfected patients with lipodystrophy sponsor Tibotec Therapeut ics Theratech nologies

10/11/10

14/3/11

Contrast agent to help detect Bayer lesions in patients undergoing magnetic resonance imaging (MRI) of the central nervous system For once-daily treatment for moderate-to-severe restless legs syndrome (RLS) GSK and Xenoport

Horizant (gabapentin enacarbil)

6/4/11

II. Standard drugs(Contd.)

Drug name
Latuda (lurasidone hydrochloride)

Approval date
28/10/10

Indication
For treatment of schizophrenia in adults

sponsor
Sunovian Pharm

LaViv (Azficel-T)

21/6/11

For improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults
For treatment of head lice infestation in patients ages 4 years and older To prevent organ rejection in adult patients who have had a kidney transplant, in combination with other immunosuppressants

Fibrocell

Natroba (spinosad) Nulojix (belatacept)

18/1/11

ParaPRO

15/6/11

BMS

II. Standard drugs(Contd.)

Drug name Potiga (ezogabine) Approval date 10/6/11 Indication For use as an add-on medication to treat seizures associated with epilepsy in adults sponsor Valeant pharm, mktd by GSK

Spherusol

29/7/11

For detection of Allermed delayed type Laboratories hypersensitivity to C. immitis in individuals, 18-64 years of age For treatment of acute bacterial skin and skin structure infections and community acquired bacterial pneumonia Cerexa

Teflaro (ceftaroline fosamil)

29/10/10

II. Standard drugs(Contd.)

Drug name Tradjenta (linagliptin) Approval Indication date 2/5/11 For use as an adjunct to diet and exercise to improve glycemic (blood sugar) control in adults with type 2 diabetes. For treatment of major depressive disorder in adults. sponsor Boehringer Ingelheim, Eli Lilly

Viibryd (vilazodone hydrochloride)

21/1/11

PGx Health

Xarelto (rivaroxaban)

1/7/11

To reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery

Janssen Pharmaceuticals, Bayer

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. 2. 3. 4. 5. 6. 7. Zytiga Zelboraf Xalkori Yervoy Adcetris Caprelsa 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 drugs1 for melanoma and 1 for lung cancerrepresent 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 6month 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.