FDA Approves Sanofi Pill for MS

By Jennifer Corbett Dooren

WASHINGTON--The Food and Drug Administration on Wednesday approved a Sanofi SA pill to treat multiple sclerosis, making it the second oral therapy for the disease to be available on the U.S. market.

Competition has steadily grown over the last decade in the multibillion-dollar-a-year market for treating multiple sclerosis, whose sufferers include Ann Romney, wife of Republican presidential candidate Mitt Romney.

Novartis AG brought the first oral pill for treating multiple sclerosis onto the U.S. market in 2010. The pill, Gilenya, recorded world-wide sales of $530 million in the first half of 2012, according to Novartis.

Sanofi's new drug, teriflunomide, will be sold under 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.

The 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 the FDA's strictest boxed warning. The warning discusses the 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 and must 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.

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FDA Approves Sanofi Pill for MS