Hit by some aggressive new generic competition and fresh from the loss last week of its patent for Lovenox [1], Sanofi-Aventis reported that the FDA has delayed a decision on its weight loss drug Acomplia for three months. That's the third delay for Acomplia and the wrong message from Sanofi-Aventis, which saw its share price slide on the news. Analysts say that Sanofi-Aventis badly needs to gain a blockbuster approval from regulators as Plavix and other big drugs face generic competition. The FDA now says it will decide on Acomplia by July, raising the possibility that the drug may also be OK'd for type 2 diabetes [2].
- read the report [3] from MarketWatch
ALSO: The FDA has restricted the use of Ketek for pneumonia to address safety concerns [4]. Release [5]
Related Articles:
Delays forecasted for blockbuster obesity drug. Report [6]
Sanofi shares slide on Acomplia delay. Report [7]
Links:
[1] http://www.fiercebiotech.com/story/sanofi-loses-lovenox-patent-protection/2007-02-12
[2] http://www.fiercebiotech.com/story/sanofi-touts-phase-ii-acomplia-results/2006-12-05
[3] http://www.marketwatch.com/news/story/sanofi-aventis-profit-down-5-plavix/story.aspx?guid=%7B53C6F6D4-923D-4879-84EF-423767276D23%7D
[4] http://www.fiercebiotech.com/story/fda-emails-raise-concerns-about-ketek/2006-07-19
[5] http://www.fiercebiotech.com/node/5650
[6] http://www.fiercebiotech.com/story/delays-forecasted-for-blockbuster-obesity-drug/2006-11-01
[7] http://www.fiercebiotech.com/story/sanofi-shares-slide-on-acomplia-delay/2006-02-21