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Amylin’s Woes Mount, Thanks to FDA Actions

Oct 13, 2008

Analysts speculate that the FDA may delay until 2011 its approval of a long-acting form of Byetta called exenatide LAR. Amylin had hoped to receive approval by 2010 by the latest.

The stock of Byetta manufacturer Amylin Pharmaceuticals has lost more than half of its value over the past eight weeks, thanks to FDA concerns that the type 2 treatment may be connected with the deaths from acute pancreatitis of six Byetta users. Although the FDA has not proven a direct association between fatal pancreatitis and the use of Byetta, Amylin's stock has fallen nevertheless.

Adding to the company's problems is speculation among financial analysts that the FDA may delay until 2011 its approval of a long-acting form of Byetta called exenatide LAR. Amylin had hoped to receive approval by 2010 by the latest.

The long-acting form, which is administered by injection once a week, is now undergoing testing under FDA auspices. Current Byetta users inject the drug twice daily, usually before the morning and evening meals.

Third-quarter sales for Byetta are expected to reach $175 million, about $6 million to $7 million less than Wall Street forecasters had predicted earlier this year.

Byetta, which controls appetite and glucose production and stimulates beta cell growth, has been on the market since 2005. It is used by approximately 800,000 people with type 2 diabetes.  


Categories: Byetta, Diabetes, Diabetes, Pens, Type 2 Issues



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