FDA panel backs 2nd diabetes combo, endorses Sanofi’s iGlarLixi

Sanofi Brandicourt CEO

The FDA’s diabetes experts provided their second endorsement for a treatment duo in two days, voting 12 to 2 to back Sanofi’s marketing application for a combination of its franchise blockbuster Lantus (insulin glargine) and the GLP-1 drug lixisenatide--now dubbed iGlarLixi. There was one abstention.

Like the unanimous vote on Tuesday favoring Novo Nordisk’s IDegLira, also a combination of insulin with a GLP-1 drug, the outside panelists were won over by the advantages patients could gain if they needed to up their therapeutic regimen for the disease. The main concern seemed focused on likely problems in treating obese patients and the threat of dosing errors in the real world, with concerns about the way the product is labeled and major issues with the way Sanofi's proposed pen devices are designed.

The review of trial data included evidence that a number of people had trouble using Sanofi's pens. But there was also a general consensus that the therapy offered a convenient new weapon in the fight against diabetes.

Ken Burman, director of the endocrine section at MedStar Washington Hospital Center, noted that he cast one of the two ‘no’ votes primarily because of problems with the pens Sanofi offered. But, he added, “I think those could be worked out.”

Brendan Everett, a cardiologist at Harvard Med, voted in favor of the combo, saying that the product would be best used among patients taking insulin glargine who require adjunct therapy.

For Bernstein’s Ronny Gal, it was clear early on that FDA insiders were uncomfortable about the possibility that patients could be shortchanged on dosing both of these drugs simultaneously while increasing the risks associated with a combo over a single therapy.

But a number of the panelists were won over by the ideal patient profile, which included a diabetic on either one of the drugs who would benefit from adding the second treatment to the regimens.

The stakes are high for both companies, with Sanofi--which used a $245 million priority review voucher to try to gain an edge over the competing product from Novo Nordisk ($NOVO)--in particular facing a tough task in getting its blockbuster diabetes franchise back on track after some shaky quarters.