Long-Acting Insulins Win FDA Panel Support

An FDA advisory committee voted 8-4 Thursday in favor of approval of a new ultra-long-acting insulin for type 1 and type 2 diabetes.


But the Endocrinologic and Metabolic Drugs Advisory Committee also voted unanimously (12-0) in support of a cardiovascular outcomes trial for the product’s two formulations, insulin degludec (Tresiba) and insulin degludec/aspart, (Ryzodeg), due to a potential signal in a meta-analysis of major trials conducted thus far.


The majority of panelists who voted in favor of approving the drug said such a trial could be done post marketing.


“I think this agent has advantages over what’s currently available,” said panelist Ellen Seely, MD, of Harvard University in Boston. “Both insulin glargine (Lantus) and insulin detemir (Levemir) were supposed to be 24-hour insulins but fell short of that. We’ve spent a long time searching for an insulin that would last 24 hours.”

Source: http://www.health.am/db/more/long-acting-insulins-win/

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