The Food and Drug Administration (FDA) has approved the type 2 diabetes injection Bydureon. Made by Amylin Pharmaceuticals, the drug is the first weekly medication to treat type 2 diabetes. Bydureon is designed to control blood sugar levels, and will be available in pharmacies this month.
“Bydureon represents an important milestone in Amylin’s promise to bring market innovation therapies to help improve the lives of people with type 2 diabetes,” Amylin president and CEO Daniel M. Bradbury said in a statement.
The market for type 2 diabetes treatments has been littered with safety concerns surrounding drugs already on the market. Last year, the FDA severely restricted Avandia after it was linked to heart attacks, many of which were fatal. A few months later, the FDA issued a warning about Actos after studies showed long-term used put patients at greater risk for developing bladder cancer.
Though the FDA approved Bydureon, the agency did raise concerns about thyroid cancer risk in animal studies, the relevance of which for humans was considered uncertain. The drug’s packaging will advise that Bydureon be prescribed only to patients for whom potential benefits are considered to outweigh the potential risk.
Amylin recently severed ties with Ely Lilly, alleging anticompetitive activity after the Indianapolis-based pharmaceutical company entered into a marketing deal with Germany’s Boehringer Ingelheim GmbH to sell a competing diabetes drug.
Amylin will have full control of its diabetes drug franchise, which includes Bydureon as well as Byetta, which contains the same active ingredient.
Source: San Diego Business Journal