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US panel recommends approval for combined type 2 diabetes drug

A type 2 diabetes combination drug which has been designed to make people’s lives easier has been recommended for approval by a US panel.
The drug, iGlarLixi, combines Sanofi’s Lantus (insulin glargine) and the GLP-1 drug Lyxumia (lixisenatide). It is currently undergoing regulatory review in Europen, according to manufacturers Zealand Pharma A/S.
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 12-2, with one person not voting, that the US Food and Drug Administration (FDA) should make iGlarLixi available to people with type 2 diabetes.
Elias Zerhouni, Sanofi’s president of global research and development, said: “We are pleased by the advisory committee’s recommendation for approval of this investigational diabetes therapy.”
Zerhouni said combining Lantus and Lyxumia would help address some of the “unmet needs of adults living with type 2 diabetes who are considering initiating or intensifying insulin”.
Concerns were raised about the packaging as the panel thought the two pens which contained two separate dose combinations might cause confusion.
Dr Robert Smith, a professor of medicine at Brown University and chairman of the panel, voted in favour of the drug.
Speaking to Reuters news agency, he said: “There’s a whole lot of concern with the hazards that come with this. We’re not objecting to the construct but there’s a real challenge here in terms of how to adequately label it.”
The panel said the preference would be to give iGlarLixi to people who had already been taking insulin or a GLP-1 drug.
The announcement comes just a day after the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) also approved a similar drug made by Novo Nordisk, called IDegLira.
The rival company’s drug combines Tresiba (insulin degludec) with its GLP-1 agonist Victoza (liraglutide), in one fixed-dose.
The FDA is likely to announce its approval decision in August.

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