Calif. Drug Maker Seeks Approval for Once-a-Week Diabetes Treatment

The makers of a once-weekly injectable treatment for diabetes are seeking Food and Drug Administration approval to sell the drug in the United States.

San Diego-based Amylin Pharmaceuticals has asked the FDA to approve exenatide LAR, an extended-release form of Byetta, the company’s diabetes drug which requires twice-daily injections. Both drugs use a protein found in the saliva of Gila monsters to help increase the body’s production of insulin.

Byetta has been found to cause deadly pancreatitis, a life-threatening disease of the pancreas. In August 2008, the FDA ordered that stronger warnings about the risks of pancreatitis be added to Byetta’s packaging. The stricter warnings came after two Byetta users died and four others had to be hospitalized after suffering injuries caused by the drug.

Exenatide LAR would rival liraglutide, a Novo Nordisk once-daily shot that is now pending FDA approvals. However, whether that drug will win FDA approvals remains uncertain. An FDA advisory panel of medical experts recently noted concerns about the risk of tumors associated with taking liraglutide and was divided over whether to recommend that it be approved. While the FDA is not required to follow the advice of its panel of experts, the agency most often does. An advisory panel is expected to review Amylin’s new-drug application for exenatide LAR.

Amylin is partnered with Eli Lilly & Co. and Alkermes Inc. in marketing exenatide LAR.

Blood Sugar Drugs are Big Money

Nearly 24 million people in the United States have diabetes, a disease in which the body cannot produce or properly use insulin, the hormone the body needs to convert sugar, starches and other foods into energy.

Drugs to treat diabetes by helping regulate blood-sugar levels are big money for drug companies including Amylin, which are pouring more and more resources into developing new diabetes treatments. By some estimates, diabetes is a $5 billion business in the U.S.

Exenatide LAR and other injectable drugs are preferred by some people because the products require lower doses to be effective compared to pills. However, many diabetics who are skittish about needles prefer to pass on injectable drugs.

Ever since another diabetes drug, Avandia, was recalled after causing increased risks of heart attack and stroke, the FDA has taken a closer look at new diabetes drugs, including exenatide LAR. In 2008, the FDA issued new safety guidelines for diabetes treatments.

Both exenatide LAR and liraglutide are members of the same class of diabetes treatments, called GLP-1 analogues.

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