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FDA approves Novo Nordisk’s Xultophy 100/3.6 for Type 2 diabetes


SILVER SPRING, Md. — Novo Nordisk announced Monday that the Food and Drug Administration had approved its Xultophy 100/3.6 (insulin degludec 100 units/ML and liraglutide 3.6 mg/mL). The drug is indicated to improve glycemic control in adults with Type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily. 


Xultophy was approved the same day as Sanofi’s Soliqua 100/33, and the two are among the first in a new class of drugs that combine a GLP-1 agonist and long-lasting insulin. In this case, it combines Novo Nordisk’s Tresiba and Victoza into a once-daily injection. 


"Novo Nordisk is committed to discovering and developing new medicines, like Xultophy 100/3.6, that may make a difference in the way some adults with type 2 diabetes manage their diabetes and achieve their treatment goals," Novo Nordisk EVP and head of North American operations Jakob Riis said. "Combining Tresiba and Victoza into a single injection will offer patients a new option that may help control their blood sugar.”


Novo Nordisk expects the U.S. launch of the drug in the first half of 2017. It will be available in a pre-filled pen. 


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