Sanofi withdraws diabetes drug application in US

Sanofi has withdrawn its New Drug Application (NDA) of diabetes drug, lixisenatide, in the United States.

The pharma company’s decision was based on the FDA’s requirement to review interim data as Sanofi believes publication of this early data, from its ongoing ELIXA cardiovascular outcomes clinical trial, “could potentially compromise the integrity of the ongoing ELIXA study“. The company has stated that its decision is “not related to safety issues or deficiencies in the NDA” and that the ELIXA cardiovascular study continues as planned.

Sanofi plans to resubmit the NDA in 2015, after the ELIXA study has finished.

Lixisenatide has already been approved in Europe under the brand name Lyxumia. The drug is part of a new class of diabetes treatments called GLP-1 analogues, which prompt the body to release insulin when a diabetic’s blood sugar level gets too high.


Related news:

Sanofi, Zealand hit by U.S. setback for diabetes drug (Reuters)

Reference links:

Sanofi press release

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.