FDA rejects Genzyme’s biological drug for MS

The US drug regulator the FDA has made a final decision on the biological drug developed by Genzyme (Sanofi) for use in multiple sclerosis, alemtuzumab (Lemtrada), failing to approve the monoclonal antibody.

Genzyme said in a Sanofi statement it had received an FDA ‘complete response letter’, to which it would appeal. Its president and chief executive was “extremely disappointed with the outcome of the review“.

“We strongly believe that the clinical development programme, 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.

This evidence was also the basis for the approvals of Lemtrada by other regulatory agencies around the world.”

Dr David Meeker, president and chief executive, Genzyme.

Genzyme said it understood the decision was related to the design of phase 3 comparator studies, and that it had been told by the FDA that another one or more comparator trials of different design and execution would be needed before a new approval decision could be considered.

 

Related news:

Sanofi MS drug Lemtrada fails to win backing of US FDA (Bloomberg).

Sanofi says US regulators reject MS treatment Lemtrada (Reuters).

Reference links:

Genzyme receives complete response letter from FDA on Lemtrada (alemtuzumab) application (Sanofi press release).

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