Thursday, December 11, 2008

FDA to Vote "Up, or Down" on Foradil, and other LABAs -- Tomorrow.


UPDATED From Reuters -- 12.11.08 @ 3:30 PM EST: ". . . .ROCKVILLE, Md., Dec 11 (Reuters) - Two asthma drugs, GlaxoSmithKline PLC's Serevent and [US Schering's] Foradil, pose serious risks that outweigh their benefits for treating adults, adolescents and children, a U.S. advisory panel ruled on Thursday. . . ."

This means that the FDA panel has recommended that Foradil not be prescribed for asthma, at all (regardless of patient age) -- and that Foradil only retain its FDA-approval for treating COPD -- a much narrower market, in the US. In any event, additional warnings, beyond the existing "black-box" language will now go on Foradil's pacakging.

Ouch.

[Item Originally Posted 12.10.08 5:03 PM EST] Reuters has today's FDA review panel summary-story -- as to US Schering's Foradil -- and the staffers' remarks from Rockville, Maryland, at the Hilton:

. . . .Reviewers in the FDA's drug safety office have recommended revoking the medicines' approval for treating asthma in children, according to documents prepared for the panel.

The reviewers also said Serevent and Foradil, which are used much less often, should not be taken by anyone with asthma.

The FDA is undecided on how to proceed and is seeking input from the panel of outside experts. . . .

Vote results to be provided, here, tomorrow. Should be interesting. As I've earlier guessed, I think Foradil will earn an FDA "split decision" -- it will likely remain on the market, but no-longer be indicated for pediatric use. UPDATE: To be clear, no one is suggesting that it be pulled for COPD. I think FDA is clear that LABAs do offer some positive risk-to-efficacy ratio, as to COPD.

2 comments:

Anonymous said...

CNN Money claims AC gave thumbs down to Foradil.

Condor said...

That seems [mostly] right. It remains approved for COPD, as I read the tea leaves.

Thanks!