Amylin, Lilly’s Byetta Wins FDA Approval as Standalone Therapy, Without Combo Drugs

Xconomy San Diego — 

San Diego-based Amylin Pharmaceuticals (NASDAQ: AMLN) and its partner Eli Lilly got some positive news late Friday from the FDA. The agency now says the companies have clearance to market exenatide (Byetta) as a standalone therapy for diabetes, which means doctors won’t need to combine it  with other common drugs, or hold it in reserve as a second option in case other drugs fail.

Exenatide is Amylin’s biggest selling product, generating $678.5 million in revenue last year, accounting for about 90 percent of its sales. An estimated 23.6 million people in the U.S, or almost one out of every 12 people, is estimated to have diabetes, so the expanded approval of Amylin and Lilly’s drug may allow the companies to capture a larger percentage of patients. The one downside is that exenatide currently requires twice-daily injections, so it’s hard to say how many new patients who are eligible for the drug will opt to take it instead of cheaper and more convenient oral pills.

“The expanded indication gives physicians the option to prescribe Byetta as a first-line treatment, increasing the number of patients who may benefit from the medication and providing an opportunity to treat patients with Byetta earlier in the disease,” said Orville Kolterman, Amylin’s senior vice president of research and development, in a company statement. “Type 2 diabetes is a complex disease, so it is essential that healthcare professionals and their patients have a wide array of treatments that can effectively control blood glucose levels.”

A more important milestone for Amylin and Lilly will come in March, when the FDA has a deadline to complete its review of a once-weekly injectable version of exenatide. That’s the next version of the diabetes franchise at Amylin that analysts say has blockbuster sales potential.