French drugmaker, Sanofi SNY, has an important regulatory event coming up this week with the FDA’s advisory panel slated to review the company’s regulatory applications for a couple of diabetes treatments.
Sanofi is looking to get a combination of insulin glargine (trade name: Lantus) and lixisenatide (a GLP-1 receptor agonist, trade name: Lyxumia) approved for type II diabetes. Lyxumia, which is approved in the EU, is currently under FDA review.
Briefing documents released ahead of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting raise concerns regarding the dosing mechanism of the combination treatment which may lead to under-dosing or dosing errors as well as practical utility.
The briefing documents also mention that inadequate dosing of insulin in the studies could have biased the estimate of efficacy in favor of the combination product.
Investor focus will remain on the outcome of the FDA advisory panel meeting. While the FDA is not required to follow the advice of its advisory panels, it usually does so. A final decision from the FDA regarding Lyxumia’s approval status is expected in Jul 2016, and for the combination treatment in Aug 2016. Sanofi had used a Priority Review Voucher for the combination treatment.
We note that Sanofi’s diabetes segment has been under pressure with Lantus facing biosimilar competition in the EU and Japan and pricing pressure in the U.S. Sanofi expects global Diabetes sales to decline 4–8% annually over the 2015–2018 timeframe.
Meanwhile, Novo Nordisk NVO is also looking to get a similar combination treatment approved by the FDA – Tresiba (insulin degludec) plus Victoza (liraglutide). This combination will be reviewed by the FDA’s advisory panel today.
Sanofi is a Zacks Rank #2 (Buy) stock. Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company BMY and Pfizer Inc. PFE. Both are Zacks Rank #1 (Strong Buy) stocks.
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