FDA Advisory Committee Recommends Sanofi’s Diabetes Combo DrugBy
The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has recommended the approval of Sanofi’s new drug application (NDA) for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with Type 2 diabetes.
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. The proprietary names for both compounds in the US are under consideration. Lixisenatide is currently approved in more than 60 countries worldwide under the proprietary name Lyxumia. 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 is Sanofi’s most important therapeutic franchise from a revenue perspective, accounting for 2015 revenues of EUR 7.58 billion ($8.48 billion). The combination therapy is important for Sanofi as it faces generic competition for Lantus (insulin glargine), its top-selling product in 2015 with sales of EUR 6.39 billion ($7.14 billion) and which saw patent expiry, effective in February 2015 in the US and in May 2015 in the European Union.