FDA Endorses Sanofi SA (NYSE:SNY) iGlarLixi

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The FDA has approved a Sanofi SA (NYSE:SNY) marketing application for a combination of its franchise blockbuster Lantus and the GLP-1 drug lixisenatide – now known as iGlarLixi, formerly LixiLan. The FDA’s diabetes expert voted 12 to 2 backing the drug with one abstention. This approval recommendation marked the second endorsement for a diabetes-related treatment in two days.

Novo Nordisk A/S (NYSE:NVO) IDegLira, a combination of insulin with the GLP-1 drug was approved the previous day just before Sanofi’s iGlarLixi. The two drugs managed to win the approval of the board by the advantages patients could gain. Sanofi had argued that treating diabetics earlier and aggressively could reduce complications from the disease that affects more than 22 million people in the United States.

FDA’s chief concern was focused on the likely emergent problems in treating obese patients and the threat of dosing errors from the way the product is labeled. There were also concerns with the way Sanofi’s proposed pen devices are designed. During the review, trial data showed evidence that some people had trouble using Sanofi’s pen though there was a consensus that the therapy offered a convenient new weapon in fighting diabetics.

Ken Burman, director of the endocrine section at MedStar Washington Hospital Center, pointed that he had voted ‘no’ primarily because of the problem with the pens though he thinks those could be worked out. Brendan Everett, a cardiologist at Harvard Medical, voted for the combo, noting that the product would be best used among patients taking insulin glargine and required adjunct therapy.

The panel also discussed concerns that the drug might cause a more allergic reaction than others in the class. They were, however, satisfied that its efficacy and safety was broadly in line with others in its class.

The stakes were high for Sanofi, which has used a priority review voucher with the aim of trying to gain an edge over competing products from Novo Nordisk. The company has also faced a shaky first quarter and is hoping to get its blockbuster diabetes franchise back on track.

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