PARIS (dpa-AFX) - Sanofi announced that the European Commission has granted marketing authorization in Europe for Suliqua, the once-daily titratable 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.
Suliqua is authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.
Marketing authorization in Europe for Suliqua is applicable to the 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway, and follows the November 2016 positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The product was approved by the U.S. Food and Drug Administration (FDA) in November 2016, as SoliquaTM 100/33, and has been available in the U.S. since January 4, 2017. Launches in individual EU countries are anticipated from the second-quarter 2017 onward.
separately, Zealand Pharma announced a US$10 million milestone payment following Sanofi's announcement of European Commission (EC) marketing authorization in Europe for Suliqua, the once-daily titratable 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.
Suliqua is authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.
Under the terms of the license agreement between Sanofi and Zealand, which covers lixisenatide and any combination product that includes lixisenatide, Sanofi is responsible for all development and commercialization, including financing hereof.
The EU approval of Suliqua triggers a milestone payment of US$10 million to Zealand. Under the agreement, Zealand is eligible to receive remaining milestone payments of up to US$100 million as well as low double-digit percentages on global sales in royalty income.
Copyright RTT News/dpa-AFX