Biotechnology Events

Home

Sanofi Insulin Glargine and Lixisenatide PDUFA

08/22/2016 - 00:00

.

FDA Accepts Sanofi New Drug Application for
Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide

- FDA decision anticipated in August 2016 -

- Regulatory submission based on results from Phase 3 clinical trial program in adults with type 2 diabetes -

Paris, France - February 22, 2016 - Sanofi announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.

Following the redemption of a Priority Review Voucher with the submission, an FDA decision is anticipated in August 2016.

"The FDA filing notification is an important milestone for Sanofi as we work to broaden our diabetes portfolio," said Pascale Witz, Executive Vice President, Global Diabetes & Cardiovascular, Sanofi. "Physicians may need to consider fasting and mealtime blood glucose imbalances in their overall management of diabetes, and additional treatment options are needed. We look forward to working with the FDA during the review process with a view toward bringing this investigational medicine to adults with type 2 diabetes in the U.S."

This NDA submission is based on data from two Phase 3 studies, which enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints and will be presented at a medical congress in 2016.

The safety and efficacy of the fixed-ratio combination have not been evaluated by any regulatory authority, and the proprietary name is under consideration. Preparations are on track for regulatory submission in the European Union in March 2016. The investigational GLP-1 receptor agonist lixisenatide was evaluated in patients with type 2 diabetes and is also currently under review by the FDA. The NDA for lixisenatide was accepted in September 2015, and an FDA decision is anticipated in July 2016.
More
Source: press release, 2/22/16. http://en.sanofi.com/NasdaQ_OMX/local/press_releases/fda_accepts_sanofi_new_drug_ap_1987801_22-02-2016!07_00_00.aspx

.

Sanofi Submits New Drug Application for the Once-Daily

Fixed-Ratio Combination of Insulin Glargine and Lixisenatide

Paris, France - December 23, 2015 - Sanofi announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide, which if approved would be administered as a single daily injection for the treatment of adults with type 2 diabetes.

"This NDA submission is a significant milestone in Sanofi's efforts to further develop our insulin franchise," said Pierre Chancel, Senior Vice President, Head of Global Diabetes at Sanofi. "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. We recognize the need for additional treatment options and look forward to working with the FDA during their consideration of our submission."

Sanofi redeemed a priority review voucher (PRV) with the submission to designate the NDA for an expedited 6-month review if the submission is accepted by the FDA, instead of the standard 10-month review.

This NDA submission is based on data from the LixiLan-O and LixiLan-L Phase III studies, which both reported positive top-line results earlier in 2015. These studies enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations uncontrolled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively.

The proprietary name for the fixed-ratio combination is under consideration. Its safety and efficacy have not been evaluated by any regulatory authority.
More
Source: press release, 12/23/15. http://hugin.info/152918/R/1975672/723010.pdf

.