Sanofi Withdraws NDA for Lixisenatide - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Sanofi Withdraws NDA for Lixisenatide



Sanofi has withdrawn its new drug application (NDA) in the United States for lixisenatide, an antidiabetes drug, which included early interim results from the ongoing ELIXA cardiovascular (CV) outcomes study. The company plans to resubmit the NDA in 2015 after completion of the ELIXA CV study.

The decision to withdraw the lixisenatide application follows discussions with FDA regarding its proposed process for the review of interim data. Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA study. According to Sanofi, the decision is not related to safety issues or deficiencies in the NDA.

The ELIXA study continues as planned and is fully enrolled. Complete results should be available in approximately 15 months. Sanofi states that the most appropriate option is to support the FDA’s evaluation of lixisenatide based on the complete results of the ELIXA study rather than interim data.

The combination of lixisenatide and Lantus (basal insulin), the investigational
LixiLan fixed-ratio product, remains on schedule to enter into Phase III in the first half of 2014.

Source: Sanofi

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
24%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
44%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Click here