September 12, 2012 / 11:45 PM / 7 years ago

Sanofi's MS pill Aubagio gets FDA greenlight

(Reuters) - Sanofi’s multiple sclerosis pill, Aubagio, is set to reach the U.S. market, after the Food and Drug Administration gave a green light on Wednesday.

Sanofi CEO Christopher Viehbacher addresses the Boston College's Chief Executives Club of Boston in Massachusetts March 6, 2012. REUTERS/Jessica Rinaldi

Aubagio is one of the two multiple sclerosis treatments the French drugmaker is relying on to return to growth after the loss of several blockbuster drugs to generic rivals.

“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” Russell Katz, director of the Division of Neurology Products at the FDA, said in a statement posted on the drug regulator’s website.

The European regulator is expected to give its response on Aubagio in the first quarter of 2013.

Compared with older therapies for MS, Aubagio has the advantage of being an oral drug.

But it has produced less impressive results in clinical tests than other oral treatments and has failed to show it was better than Merck’s Rebif, a commonly used injectable drug for MS, although Aubagio has milder side effects.

Analysts expect the drug could find favor among newly diagnosed patients, since around 35 percent to 40 percent of MS patients prefer to take no medication rather than face unwanted side effects.

MS pills Gilenya by Novartis and Biogen Idec Inc’s BG-12 are seen dominating a market that JPMorgan analysts predict growing to $14 billion in 2015 from $9.6 billion last year.

Aubagio is seen grabbing a much smaller chunk of this market, reaching modest sales of $353 million in the United States and five major European countries by 2020, according to business intelligence firm Datamonitor.

Multiple sclerosis, which has no cure, affects 2.5 million people worldwide. It is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision.

In addition to Aubagio, Sanofi has filed MS injectable drug Lemtrada with regulators.

Despite a recent setback at the FDA, when the regulator asked Sanofi to refile its marketing application for the drug, Lemtrada could be launched in 2013 if it wins approval.

Reporting by Elena Berton in Paris and Tej Sapru in Bangalore; Editing by Steve Orlofsky

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