Amylin gains on FDA complete response

Amylin gained $3.24 (16%) to $23.50 on Monday after FDA issued a complete response letter for an NDA for Bydureon exenatide once weekly to treat Type II diabetes. According to the company, the letter primarily included requests related to the finalization of product labeling with a REMS and clarification of existing manufacturing processes. Amylin said the agency did not request any new preclinical or clinical trials for the long-acting release formulation of synthetic exendin-4, a glucagon-like peptide-1 (GLP-1) analog. The company expects to submit a response to the agency in the next few weeks.

Amylin also said the letter did not contain requests related to the findings of a December 2009 inspection of a West Chester, Ohio, manufacturing facility, which FDA posted on its website last Thursday. Amylin said the 10 observations from that inspection have been addressed (See BioCentury Extra, Friday, March 12, 2010). ...