The FDA approved 35 new drugs in fiscal year 2011, the highest number in over a decade. Twenty-four of these drugs were approved before any other country. Ten drugs were approved to treat rare or orphan diseases. The document provides details on the newly approved drugs, dividing them into two categories: priority drugs which treat serious or life-threatening conditions, and standard drugs which fill unmet medical needs. Key priority drugs were approved to treat cancers like lung cancer and melanoma, as well as hepatitis C and lupus.

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

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.