Panel Backs Astra’s, BMS’ Saxagliptin 10-2
April 1, 2009 at 3:46 pm EST | Tags: Drugs, FDA, Filings & Approvals
In more big diabetes news, an FDA panel today backed AstraZeneca’s and Bristol-Myers’ Saxagliptin, claiming that the dipeptidyl peptidase-4 (DPP-4) inhibitor for type 2 diabetes doesn’t appear to increase the risks of heart attacks and strokes. The FDA should make a final decision later this month and although it doesn’t have to go along with advisory panel decisions, it usually follows its advice.
The FDA’s increased concern about cardiovascular side effects is due mainly to a research paper published in 2007 linking GSK’s Avandia to an increased risk of heart attack. The agency issued new regulatory approval guidelines for type 2 diabetes drugs in December 2008, long after applications for saxagliptin, as well as Novo’s liraglutide, were submitted.
Today’s news comes one day after the FDA said it had concerns regarding Novo’s liraglutide, citing cardiac and thyroid issues.
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