Friday, January 27, 2012

Alkermes finally wins OK of diabetes drug

By Rodney H. Brown

Alkermes Inc. and its California partner Amylin Pharmaceuticals Inc. have finally won approval from the FDA for the diabetes drug Bydureon after years of attempts.

In a letter from the U.S. Food and Drug Administration’s Office of Drug Evaluation, the two partners were told that the New Drug Application that had originally been submitted in May 2009 was approved and the contents of package labels should be sent to the office as soon as possible.

Following the original application in 2009, the FDA issued a complete response letter in March 2010, requesting additional data before the potential drug could be approved. Bydureon is a longer acting form of the already-approved drug, Byetta. Byetta has been associated with acute pancreatitis, which can be fatal. It should not be used by people who have severe kidney problems, according to the drug’s label.

A second attempt at answering the FDA’s concerns in October 2010 also failed to win approval of the drug.

Now approved, Bydureon is the first type 2 diabetes treatment taken once weekly.

In May 2011, Alkemes bought the Elan Drug Technologies unit of Ireland’s Elan Corp. plc in a cash and stock merger deal worth approximately $960 million that saw Alkermes Inc. relocate its headquarters officially to Dublin, Ireland, and become Alkermes plc.