Quality over Quantity of drug approvals in 2011
By Kim Bill on Sep 2, 2011 | In Drug Development
EvaluatePharma, a partner of ALSA published a commentary that 24 new drugs have been already been approved by the FDA in 2011 and we will likely beat the total number of drugs (26) approved in 2010 . PS: as of the date of this posting, there 2 additional approvals!
QUANTITY is not quite as important as QUALITY and we think that the quality of drugs approved this year could be the best in 15 years, addressing real unmet needs in melanoma, Hepatitis C, Lupus-- this is reflected in the forecasted combined peak 5th- year sales of $14.6 Billion
FDA approvals in 2011
1. Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011
2. Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011
3. Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011
4. *Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March 2011
5. *Brilinta (ticagrelor); AstraZeneca; For the reduction of thrombotic events in patients with acute coronary syndrome, Approved July 2011
6. Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011
7. Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011
8. Edarbi (azilsartan medoxomil); Takeda; For the treatment of hypertension, Approved February 2011
9. Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 2011
10. Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011
11. Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of restless legs syndrome, Approved April 2011
12. *Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011
13. laViv (azficel-T); Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, Approved June 2011
14. Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011
15. Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm birth, Approved February 2011
16. Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011
17. Potiga (ezogabine); Valeant Pharmaceuticals; For the treatment of partial-onset seizures, Approved June 2011
18. Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011
19. Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011
20. Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011
21. Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011
22. *Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011
23. *Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011
24. Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011
*Touted as potential blockbusters
On the other side of the coin is John L. LaMattina's Aug 2011 article in Nature Reviews where he questions the impact of mergers on pharmaceutical R&
productivity. In a nutshell, his hypothesis is more mergers, less companies and hence less drugs.
The heyday of new drug approvals by the US (FDA) were the 90s- with an average of 31 drugs per year between 1990 and 1999 compared with 24 per year between 2000 and 2009
The peak was 54 drugs approved in 1996.
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