PDUFA date for Exenatide Approaching (Nasdaq:AMLN), (NYSE:LLY)

Exenatide is a drug that has been co-developed by Amylin Pharmaceuticals, Inc, (Nasdaq:AMLN), Alkermes, Inc. (Nasdaq: ALKS) and Eli Lilly and Company (NYSE:LLY). Exenatide is currently available in the market as BYETTA® injections. However, now the three companies want to use exenatide as a drug given once per week to treat people suffering from type 2 diabetes (by controlling the glycemic level in the body). For this purpose, they submitted a new drug application (NDA) to the United States of America’s Food and Drug Administration (FDA) to get the regulator’s approval for bringing exenatide once weekly into the market. The NDA was submitted on May 5, 2009. And in June 2009, the FDA announced that the NDA contains all the information that would allow it to make a thorough review on exenatide – that is, the NDA was accepted for review. The FDA also handed the company a Prescription Drug User Fee Act goal date – also called Action date or just PDUFA date – of March 7, 2010. However, recently the FDA was closed for 5 days due to bad weather conditions. As a result, on February 25, 2010, the companies disclosed to its stakeholders that the FDA needed more time to review the NDA applications with PUDUFA dates earlier than March 7, 2010. This meant that the PDUFA date of exenatide’s NDA got extended. The new PDUFA date is March 12, 2010.

The NDA submission contains data from the Duration-1 trial conducted by Amylin Phatmaceuticals, Inc. The trial compared the safety and the effectiveness of the exenatide once weekly manufactured with the exenatide that was developed earlier.

If the Food and Drug Administration approves the NDA, exenatide would be the only type 2 diabetes treatment that can be prescribed only once every week. Daniel M. Bradbury, who is the Chief Executive Officer (CEO) as well as the President of Amylin, is confident that the NDA would be successful in getting the FDA’s approval. He said:

“The exenatide once weekly submission is an important milestone in the overall exenatide development program. The clinical data supporting this submission highlight the potential of exenatide once weekly to significantly advance the treatment of type 2 diabetes. We remain committed to developing and commercializing a range of treatment options that address the important unmet needs of people living with diabetes.”