Sanofi Submits Application for Single Daily Insulin Injection, LixiLan, for Type 2 Diabetes Treatment

Sanofi, a French pharmaceutical company, has submitted an application to the US Food and Drug Administration (FDA) for the approval of LixiLan, a single daily insulin injection that can treat people with type 2 diabetes. The company has also requested a six-month review of the application, which is a significant reduction from the standard 10-month review period. Pierre Chancel, Sanofi's diabetes head, highlighted the unmet medical need for people with type 2 diabetes, noting that more than half are not at their blood sugar goal despite using oral medications or insulin.

Key Takeaways:

Sanofi has submitted an application to the FDA for the approval of LixiLan, a single daily insulin injection for type 2 diabetes treatment.
The company has requested a six-month review of the application, which can be expedited to just six months if approved.
LixiLan is a fixed-ratio combination of lixisenatide and insulin glargine, a new single-injection treatment for type 2 diabetes.
Sanofi's submission involves a combination of insulin glargine with its lixisenatide drug, which has been linked to a $20 million milestone payment to Zealand.
The application is part of a new drug submission, which has redeemed a Priority Review Voucher.
If FDA approves the application, Sanofi will receive a Priority Review Voucher, which can be used for future submissions.
Sanofi has also expressed plans to submit an application for LixiLan in Europe in the first quarter of next year.

Statistics:

More than half of people with type 2 diabetes are not at their blood sugar goal despite using oral medications or insulin (Source: Pierre Chancel, Sanofi's diabetes head, as quoted in the article).
The standard review period for a New Drug Application (NDA) is 10 months (Source: FDA website).
Sanofi has redeemed a Priority Review Voucher as part of the US submission (Source: Sanofi statement).
A six-month review of the application can be expedited if approved (Source: Sanofi statement).
LixiLan is a new single-injection treatment for type 2 diabetes (Source: Sanofi statement).
The application to the FDA involves a combination of insulin glargine with Sanofi's lixisenatide drug (Source: Sanofi statement).
The submission for LixiLan is linked to a $20 million milestone payment to Zealand (Source: Sanofi statement).

Sources:

Sanofi statement
Pierre Chancel, Sanofi's diabetes head, as quoted in the article
FDA website
Zealand confirmation of Sanofi's application to the FDA