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Sanofi pulls Lyxumia's US filing

Says will resubmit diabetes drug for FDA approval in 2015

Sanofi Lyxumia lixisenatide diabetes 

Sanofi has taken the surprising step of withdrawing the US licence application for its key new drug for type 2 diabetes.

Lixisenatide was approved in Europe, where it is marketed under the brand name Lyxumia (pictured above), in March this year and US approval had looked to be on course.   

But, citing FDA data review processes that would "compromise  the  integrity" of an ongoing cardiovascular outcomes study, Sanofi has shelved its US plans until the ELIXA study is completed.  

Early interim data from ELIXA formed part of lixisenatide's application dossier and the pharma company's decision to halt the drug's filing came after discussions with the FDA about its proposed review process for the data.  

“Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA study,” the firm said in a statement.  

It added that the decision was not related to safety issues or deficiencies in its New Drug Application for lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist  

The global Evaluation of LIXisenatide in Acute coronary syndrome (ELIXA) study began in 2010 and involves 6,000 patients who, having recently experienced an acute coronary event, have a high cardiovascular risk.  

Full results from the trial should be available in about 15 months and Sanofi expects to be able to resubmit lixisenatide to the FDA for approval in 2015. But the decision to put its filing on hold because of the study is likely to place its results under even greater scrutiny when they are released.  

In the meantime, studies of the LixiLan combination of lixisenatide and Sanofi's blockbuster insulin Lantus remain on course and are scheduled to enter phase III in the first half of 2014.

Article by
Dominic Tyer

13th September 2013

From: Sales



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