FDA Approval Sought For Once-Weekly Diabetes Treatment
Amylin Pharmaceuticals Inc. said Tuesday that it has sought approval from the U.S. Food and Drug Administration (FDA) for its much-anticipated exenatide LAR, a once-weekly injectable diabetes treatment.
The drug is an extended version of Byetta, a twice-daily injectable consisting of a version of a protein found in Gila monster saliva.
Wall Street is looking to exenatide LAR to reinvigorate Amylin’s sales. Last year, sales of Byetta had plummeted 32 percent to $430.2 million due to safety concerns.
Because the drugs are injections, the lower dosing schedule of exenatide LAR is viewed as an advantage. The drug would likely compete with Denmark-based Novo Nordisk’s once-daily injection liraglutide, which is currently under FDA review.
Drugs that help diabetics control blood sugar have become a focus for developers because the treatments must be taken long-term to manage the chronic condition. In the U.S. alone, the market for diabetes drugs is roughly $5 billion annually.
Amylin’s partners on Byetta and exenatide LAR include Indianapolis, IN-based Eli Lilly & Co. and Cambridge, MA-based Alkermes Inc.Â
Novo Nordisk received a split recommendation from its FDA expert panel review, with members voicing safety concerns over tumors associated with liraglutide. Although the FDA is not required to follow its panels’ recommendations, it typically does.
That recommendation has some on Wall Street concerned about exenatide LAR, which will also be reviewed by such an expert panel.
Last year, the FDA issued new safety guidelines for diabetes treatments after concerns that surfaced in 2007 over heightened heart attack risks with GlaxoSmithKline’s Avandia.
Exenatide LAR and liraglutide are part of the same class of diabetes treatments known as GLP-1 analogues, which help increase the body’s insulin production.
Amylin Pharmaceuticals Inc. is cutting more than one-third of its sales force, or roughly 200 jobs, as it combines its specialty drug and primary care sales units.
Shares of Amylin’s stock rose .27 cents, or 2.33 percent, on Tuesday, closing at $11.85.Â
—
On the Net: