Sanofi-Aventis to appeal FDA rejection of MS treatment

Sanofi-Aventis has today (December 30th) confirmed its US unit Genzyme is to appeal the US Food and Drug Administration's (FDA's) decision not to approve its Lemtrada treatment for multiple-sclerosis (MS).

According to the body, the application cannot proceed at the current time because the firm has not submitted enough evidence to support the view the benefits of the drug outweigh its side-effects. 

Sanofi expected the drug to be approved by March 31st 2014 and believes it will now lose out on contingent value rights. 

David Meeker, chief executive and chairman of Genzyme, said: "We strongly believe that the clinical development program – which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo – provides robust evidence of efficacy and a favourable benefit-risk profile."

The drug is currently under review in a number of countries, but has been approved for use within the European Union, Canada and Australia – something Mr Meeker stated supports the application to the FDA.