Sanofi diabetes drug Sulinqua green-lighted in Europe
Sanofi’s diabetes drug Suliqua has been granted marketing authorisation by the European Commission, giving the go ahead for the launch of the drug in the 28 member states of the European Union.
The drug is a titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of type 2 diabetes. According to the marketing authorisation, it has been cleared for use in combination with metformin to improve glycemic control in patients who have not responded to metformin alone, metformin combined with another glucose-lowering product, or with basal insulin.
The EC reached the decision based on the results of two Phase 3 studies covering 1,900 participants; Suliqua was shown to generate significant reductions in blood sugar (HBA1c) when compared to lixisenatide and insulin glargine 100 Units/mL in LixiLan-O, and versus insulin glargine 100 Units/mL in LixiLan-L.
“Sanofi has a long history of elevating care for people with diabetes, and we believe Suliqua will make it easier for patients with inadequately controlled diabetes to reach their treatment goals,” commented Elias Zerhouni, president of Global R&D at Sanofi.
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