So, GlaxoSmithKline escapes Gaithersburg with a 20-3 vote that Avandia may increase the risk of heaving a heart attack, but a 22-1 vote that the diabetes drug should stay on the market. And maybe, or maybe not, with a so-called "Black Box" warning. That'll be up to the FDA.
Glaxo's top U.S. exec, Chris Viehbacher, told me after the panel meeting yesterday evening that he didn't see what amounted to a mandate or consensus on the committee regarding a black-box, so the company would work with the FDA to presumably tame the severity level of the safety warning.
GSK shares staged a relief rally in after-hours trading. Investors feared the panel might recommend the drug's withdrawal from the American market which is responsible for about $2 billion a year in sales or about two-thirds of the pill's worldwide annual revenue.
On the heels of that dodged bullet, something else could break Glaxo's way tomorrow. The FDA is expected to decide whether to approve Glaxo's new migraine drug, Trexima. GSK partnered with Pozen on it. The drug is a combo of Glaxo's blockbuster migraine treatment, Imitrex, and the over-the-counter pain pill Aleve. Tests show when they're mixed together some patients get faster, longer-lasting relief.
Tune in to CNBC tomorrow to watch my report on Trexima, the large, relatively untapped migraine market and who else is working to address it. Would you believe Allergan's Botox? Not to make light of a migraine, but imagine the two-fer of getting rid of debilating headaches and those fine lines and wrinkles with one "injectable". Women, by a huge margin, suffer migraines more than men.
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