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Pharmaceutical industry

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

Strategic Insights

— 1 min read

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
  • G. D. Technologies, Copyright 2015, distributed by Contify.com

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