Possible Once-Weekly Diabetes Drug

Amylin Pharmaceuticals Inc, a well known biotechnology company whose name is related to numerous medications, has asked the Food and Drug Administration to approve its highly anticipated once-weekly injectable diabetes treatment exenatide LAR.

The drug is an extended-release version of Byetta, which is injected twice daily and is a version of a protein found in Gila monster saliva. Wall Street sees Byetta and the new extended-release version as a way for Amylin to reinvigorate sales. Byetta sales fell over 30 percent in 2008 to $430.2 million because of safety concerns.

Because the drugs are injected either twice daily (Byetta) or the new extended release version at once-weekly, this will be a positive marketing tool for the company, as many diabetics must inject themselves many more times in a day. The thought of limiting the amount of injections is good news to them.

The drug’s competition would likely include Novo Nordisk’s once-daily injection liraglutide, which is currently under FDA review. Denmark-based Novo Nordisk received a split recommendation from its expert panel review at the FDA, with members expressing safety concerns over tumors associated with liraglutide. The FDA is not required to follow its panels’ advice, though it normally does.

There are new FDA safety guidelines for diabetes treatments which were issued last year after concerns about higher risk of heart attacks from Avandia, a diabetes medication fro GlaxoSmithKline. They will be looking carefully at all the new medications for diabetes, since many are of the same class of treatment, though all of them help increase the body’s indulin production.

Developers are looking closely at drugs that help diabetics control blood sugar because the drugs must be taken long-term to control the chronic condition meaning long term and continuous sales. The U.S. market for diabetes drugs is worth about $5 billion per year.

At any rate, we can only wait and see whether individuals with diabetes will receive some relief from the new weekly injection if the FDA approves it.

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