Multiple Sclerosis drug gets FDA approval

Sanofi SA said on Saturday its U.S. subsidiary Genzyme has received approval from the Food and Drug Administration for its multiple sclerosis drug Lemtrada after an initial rejection in December last year.

Lemtrada is now the second multiple sclerosis drug by Genzyme to get approval in the U.S. since Sanofi bought Genzyme for over $20 billion in 2011. The drug was one of the main drivers of the takeover.

“Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said David Meeker, president and chief executive of Genzyme.

Genzyme once forecast peak annual Lemtrada sales of $3.5 billion. In 2013 investment bank Jeffries forecast the drug would generate annual sales of $512 million by 2017. In the first nine months of this year, Lemtrada recorded €18 million sales outside the U.S.

The FDA had approved in 2001 the active ingredient alemtuzumab, to treat leukemia. But the FDA rejected Lemtrada in December 2013 citing concerns over serious side effects and the design of Sanofi’s clinical trials. Sanofi resubmitted an application to the FDA in April.

For safety reasons, Lemtrada is reserved for patients that have inadequate responses to two or more other drugs for the treatment of multiple sclerosis.

The Lemtrada label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions and serious and life-threatening infusion reactions, Sanofi said.

The warning also notes Lemtrada may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders, said the company.

The FDA approval of the drug is based on two randomized Phase III open-label rater-blinded studies comparing Lemtrada with Rebif, another multiple sclerosis treatment drug, Sanofi said.

“Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval,” said Mr. Meeker.

Lemtrada will only be available in the U.S. through a restricted distribution program that will help detect and manage the risks associated with the treatment, Sanofi said.

First approved in September 2013 in the European Union, Lemtrada is approved in more than 40 countries, Sanofi said. Additional marketing applications for Lemtrada are under review by regulatory agencies around the world.

This article was originally published on 15-11-2014 on The Wall Street Journal

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