Genzyme’s MS drug Lemtrada wins approval from European regulators

Genzyme, now a Cambridge-based unit of the French drug giant Sanofi, said that regulators have given it approval to market a multiple sclerosis drug in the European Union.

The drug is called Lemtrada, and it is one that Genzyme has high hopes for.

Genzyme has a heritage in developing drugs for rare diseases. Now it is also looking to be a presence in the MS space, which analysts have estimated to be a $13 billion market. Another Massachusetts company, Biogen Idec, is already a major player in MS drugs.

In a press release, Genzyme said Lemtrada has been indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

A few weeks ago, European regulators granted approval to Aubagio, another Genzyme MS drug. MS, a disease estimated to affect more than 2.1 million people globally, is said to require highly individualized treatment approaches. Genzyme said it intends to begin launching both products in the European Union soon.

The approvals of Lemtrada and Aubagio in the European Union represent an important milestone for Genzyme and demonstrate our focus on scientific innovation and commitment to multiple sclerosis patients,Genzyme chief executive and president David Meeker, MD, said in a statement.This is particularly exciting as the EU approval is the first for Lemtrada globally.We look forward to making these unique therapies available to MS patients very soon.

The companys press release noted that FDA action on Genzymes supplemental Biologics License Application seeking US approval of Lemtrada for the treatment of relapsing MS is expected in late 2013. Lemtrada is also under review by other regulatory agencies.

Aubagio is approved to treat relapsing MS in the United States, Australia, Argentina, Chile, and South Korea, and is under review by additional regulatory agencies, the release said.

Sanofi bought Genzyme for $20.1 billion in 2011.

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Genzyme’s MS drug Lemtrada wins approval from European regulators