French pharma major Sanofi (Euronext: SAN) has received marketing authorization in Europe for its diabetes therapy Suliqua, known as Soliqua (insulin glargine and lixisenatide combination) in the USA.
The decision enables Sanofi to start commercializing the drug in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. The company intends to begin launching in individual countries in the second quarter of 2017.
The product was approved by the US Food and Drug Administration in November 2016, and has been available there since the start of this year for the treatment of adults with type 2 diabetes.
The company’s sales in this therapy area are under pressure as its key product, Lantus (insulin glargine), faces increasing competition from biosimilars in several European countries and Japan. Lantus accounted for 17% of revenues in 2015.
Eli Lilly (NYSE: LLY) and Boehringer Ingelheim’s Basaglar (insulin glargine) was the first biosimilar insulin to receive regulatory approval in the EU, in September 2014.
“Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe,” said Elias Zerhouni, president of global R&D at Sanofi.
“The approval of Suliqua represents the successful culmination of a concerted effort by Sanofi scientists to bring two injectable treatments together in a single and precisely titratable dose.”