US FDA committee recommends approval of Sanofi’s combination therapy for type 2 diabetes
pharmafile | May 26, 2016 | News story | Research and Development, Sales and Marketing |
French drug firm Sanofi (Euronext: SAN) said the US Food and Drug Administration (FDA) advisory committee has recommended the approval of the New Drug Application (NDA) for its trial drug to treat type 2 diabetes.
The 15-member panel voted 12 to 2 in favor of the combination of basal insulin glargine and GLP-1 receptor agonist lixisenatide, the company said in a statement.
Elias Zerhouni, president, global R&D, Sanofi said: “By combining the complementary therapeutic effects of insulin glargine on fasting plasma glucose and of lixisenatide on postprandial plasma glucose, both of which can contribute to HbA1c lowering, this fixed-ratio product may address some of the unmet needs of adults living with type 2 diabetes who are considering initiating or intensifying insulin.”
The news comes days after the FDA staff questioned the benefits of Sanofi’s diabetes drug candidate as well as raised doubts over the results of clinical trials showing superiority over insulin. The combination treatment involves Sanofi’s Lyxumia (lixisenatide) with Lantus (insulin glargine), which imitates a hormone called GLP-1 to stimulate natural insulin production. The combination treatment is approved in Europe but not in the US. A final decision from the FDA regarding approval for the treatment is expected by August 23.
Lixisenatide and the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide are undergoing FDA review, with decisions anticipated in July and August 2016, respectively. Lixisenatide is currently approved in more than 60 countries worldwide. The fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide was submitted for regulatory review in the European Union in March 2016 and has not yet been approved for use by any health authority.
Diabetes affects about 29 million people in the US and is the seventh-leading cause of death, according to statistics.
Anjali Shukla
