U.S. panel backs approval of Sanofi combination diabetes drug

[May 26, 2016]  By Toni Clarke

(Reuters) - One day after recommending approval of a new diabetes drug made by Novo Nordisk A/S, a U.S. advisory panel on Wednesday recommended approval of a similar product made by Sanofi SA.

The panel voted 12-2, with one person not voting, that the Food and Drug Administration should approve Sanofi's combination drug, iGlarLixi, for patients with type 2 diabetes. The agency is not obliged to follow the advice of its advisory panels but typically does so.

IGlarLixi combines Sanofi's insulin drug Lantus with its experimental diabetes treatment lixisenatide, a member of a class of drugs known as GLP-1 agonists that also includes Novo Nordisk's Victoza and AstraZeneca Plc and Bristol-Myers Squibb Co's Byetta and Bydureon.

The companies argue that treating diabetes earlier and more aggressively can stave off complications from diabetes, a chronic metabolic condition affecting more than 22 million people in the United States that can lead to heart disease, blindness and limb amputations.

Sanofi's iGlarLixi was received more coolly by the panel than Novo Nordisk's combination, iDegLira. Panelists were particularly concerned about the way Sanofi's drug would be packaged and labeled. Two separate dose combinations would be delivered in two separate injection pens.

Dr. Robert Smith, a professor of medicine at Brown University and chairman of the panel, voted in favor of the drug but like others on the panel said his vote was contingent on the company adequately addressing concerns that the two pens could get confused, leading to medication errors.

"There's a whole lot of concern with the hazards that come with this," Smith said. "We're not objecting to the construct but there's a real challenge here in terms of how to adequately label it."

Lixisenatide by itself is an experimental drug. The panel discussed FDA concerns that the drug may cause more allergic reactions than others in the class but were satisfied that its safety and efficacy was broadly in line with others in its class.

The panel raised no objections to lixisenatide's approval and specifically recommended approval of iGlarLixi. Panelists said they would prefer to give iGlarLixi to patients who were already taking either insulin or a GLP-1 drug.

But they said they would like the company to conduct an additional study to confirm that patients who transition from a GLP-1 drug do as well as when they transition from an insulin product.

An FDA approval decision on lixisenatide is expected in July and on iGlarLixi in August.

(Reporting by Toni Clarke in Washington; Editing by Bernard Orr and Peter Cooney)

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