FDA Approves Sanofi MS Drug Aubagio

By Jennifer Corbett Dooren

WASHINGTON--The U.S. Food and Drug Administration Wednesday approved a Sanofi SA (SNY, SAN.FR) pill to treat multiple sclerosis, making it the second oral therapy that will be available on the U.S. market.

The drug, teriflunomide, will be sold with the brand name Aubagio to treat people with the relapsing remitting form of MS.

Multiple sclerosis is a progressive disease that involves damage to nerves controlling muscles and vision; it affects about 400,000 Americans and 2.5 million people world-wide.

The condition causes the body's immune system to eat away at the protective covering of the nerves, or myelin, which disrupts the electrical signals between the brain and the rest of the body. Most MS patients are of the "relapsing- remitting" type, where the disease flares up periodically and largely disappears for long periods of time.

Aubagio will compete with Novartis AG's (NVS) oral pill Gilenya, which was approved by the FDA in 2010 and has been available in Europe since 2011.

FDA said a clinical trial showed the relapse rate for patients using Aubagio was about 30% lower than the rate for those taking a placebo, or sugar pill.

The product was approved with FDA's strictest boxed warning discussing risk of liver problems, which can lead to death, and birth defects. The agency said women of child-bearing age need to have a negative pregnancy test before starting Aubagio drug and use birth control during treatment.

The FDA also said doctors should use blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment.

Write to Jennifer Corbett Dooren at jennifer.corbett@dowjones.com

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FDA Approves Sanofi MS Drug Aubagio