Is expected bad news better than unexpected bad? Ask Novartis. Today the company announced the FDA's rejection of the Cox-2 painkiller Prexige--a thumbs-down that CEO Daniel Vasella predicted last week [1]. But it might not be the agency's final word.
Prexige, of course, was banned in Australia [2] last month, after reports of severe liver-related side effects--including two deaths. Now, the company says it won't give up on the drug; the FDA is open to exploring the use of Prexige in people who might benefit most, such as ulcer patients who can't take other pain remedies.
Meanwhile, apparently looking for ways to wipe Prexige's slate clean, Novartis has asked the FDA for another approval--to change the drug's brand name.
- see this press release [3] from Novartis
- read more [4] from Swiss Info
Related Articles:
Australia bans Novartis' Prexige. Report [2]
Novartis CEO Vasella doubtful of Prexige approval. Report [1]
UK doctors warned over Novartis' Prexige. Report [5]
Links:
[1] http://www.fiercepharma.com/story/spotlight-vasella-doubtful-prexige-approval/2007-09-13
[2] http://www.fiercepharma.com/story/australia-bans-novartis-prexige/2007-08-13?utm_medium=nl&utm_source=link
[3] http://www.fiercebiotech.com/press-releases/press-release-prexige-receives-not-approvable-letter-us-despite-being-one-most-studie
[4] http://www.swissinfo.org/eng/front/detail/US_watchdog_rejects_Novartis_painkiller.html?siteSect=105&sid=8257338&cKey=1190883860000&ty=st
[5] http://www.fiercepharma.com/story/uk-doctors-warned-over-novartis-prexige/2007-08-16