FDA Says "Snow" To Lilly, Amylin & Alkermes
The Food and Drug Administration says its decisions are always based on the science. But on rare occasions ol' mother nature apparently can get in the way.
Usually the FDA delays a decision on whether to approve or reject a drug because the agency simply needs some more time, wants more data, a company didn't cross a "t" or dot an "i" on its application, etc.
But Eli Lilly , Amylin Pharmaceuticals and Alkermessay the FDA has told them it needs another week to review their application for approval of the first once-a-week diabetes drug because it lost five days of work during the recent snowstorms. The agency is located just outside of Washington, DC.
The FDA had been scheduled to make a decision on the drug on or before March 5th. The drug is a reformulation of the current twice-a-day injectable Byetta. Lilly and Amylin are partners on it and Alkermes , which stands to collect a sales royalty, provides the technology that makes the drug stay in the body for a week. Studies show it not only helps diabetics lower their blood sugar levels, but also helps them shed some pounds. But the one-week delay doesn't seem to have put an end to the debate among analysts and investors about whether the FDA will still wait for more study results on safety and suspected side effects in lab rodents before making a call.
A bullish "Diabetic Investor" newsletter writer David Kliff tells subscribers, "So it looks like we'll just have to wait one more week for the approval." While Jon LeCroy at Hapoalim Securities says he thinks the delay increases the odds of the FDA sending the companies what's called a "Complete Response Letter." That's essentially a euphemism for more delay, meaning the agency would spell out what else it wants/needs to see in order to make its decision. So, LeCroy doesn't think once-a-week Byetta gets approved until the middle of next year.
Not surprisingly, ALKS CEO Richard Pops, so far, has been silent on Twitterabout the latest development. Although, I suspect he and execs at the other two companies are probably just hoping spring comes early.
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