Sanofi requests Six-month Review of New Diabetes Drug application by FDA

French multinational pharmaceutical company Sanofi said today it has submitted an application to the USFDA for the approval of type 2 diabetes single daily treating insulin injection, LixiLan.

The company also requested the FDA for a six-month review of the application, rather than 10-month review, Sanofi said in a statement. Pierre Chancel, Sanofi’s diabetes head, said, “A large unmet medical need still exists for people with type 2 diabetes, as more than half are not at their blood sugar goal despite using oral medications or insulin”.

The Paris headquartered company also revealed that the application to FDA involves a combination of insulin glargine with its lixisenatide drug. As per a part of submission of new drug, Sanofi has redeemed a Priority Review Voucher as part of the US submission. If FDA approves the company’s NDA, it will review the drug for just six months, rather than 10 months.

Zealand also confirmed Sanofi’s application to the FDA. The submission for LixiLan is linked to a $20 million milestone payment to Zealand from the French drug-maker.

Sanofi’s LixiLan is a new single-injection which is fixed-ratio combination of lixisenatide and insulin glargine. According to the company, the injection will prove helpful in the treatment of Type 2 diabetes. There are reports that Sanofi could submit application for the approval of the injection in Europe in first quarter of the next year.

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