Sanofi’s (SNY - Free Report) new drug application (NDA) for its basal insulin candidate, Toujeo, has been accepted for review by the FDA. Toujeo is a new formulation of Lantus (insulin glargine). The FDA is expected to render a final decision on the candidate in the first half of 2015.
The NDA for Toujeo was submitted on the basis of encouraging data from the phase III EDITION studies, which evaluated the efficacy and safety of Toujeo in more than 3,500 patients suffering from diabetes. Toujeo is already under regulatory review in the EU.
Last month, Sanofi released data from a pooled analysis of Toujeo. According to the data, significantly fewer low blood sugar events (hypoglycemia) at any time of the day, including night-time events, were observed in patients receiving Toujeo as compared to Lantus.
Lantus is one of the top-selling drugs at Sanofi. The drug generated sales of €1.4 billion in the first quarter of 2014. However, we note that Eli Lilly and Co. (LLY - Free Report) along with partner Boehringer Ingelheim is looking to get their generic version of Lantus approved in the EU. The candidate has already received a positive opinion from the Committee for Medicinal Products for Human Use.
Toujeo on approval is expected to strengthen Sanofi’s product portfolio. In order to boost its diabetes portfolio, Sanofi is also developing LixiLan, a fixed dose combination of Lantus and Sanofi’s Lyxumia (once-daily injectable glucagon-like peptide 1/GLP-1 receptor agonist). In the first quarter of 2014, the company initiated two phase III studies on the candidate.
Although Sanofi holds a strong position in the diabetes market, we note that the market includes players like Novo Nordisk (NVO - Free Report) and Eli Lilly.
Sanofi carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector, Biogen Idec Inc. (BIIB - Free Report) , holds a Zacks Rank #1 (Strong Buy).