FDA Approves Drug Aubagio for Multiple Sclerosis

FDA approves a new pill to treat people with multiple Sclerosis in the United Sates.  Sanofi SA has won the approval for the pill Aubagio that will be effective in treating  the chronic disease.

"We are very excited to introduce Aubagio as a new treatment option that can make a difference in the lives of people with multiple sclerosis," David Meeker, president and chief executive officer of Sanofi's Genzyme unit, said in a statement quoted by Bloomberg. "The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community."

Till date drugs available for the patients of multiple sclerosis was through injections. But this is a new oral therapy.

Multiple Sclerosis a chronic disease that affects more than 400,000 Americans and nearly 2.5 million people worldwide.

"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 Food and Drug Administration was quoted in Reuters.

Cheuvreux analyst Marcel Brand says peak sales of Aubagio of 1.48 billion euros by 2018. "Although Aubagio is not as effective on relapse rates as Gilenya, it's free of its longer-term side effects," quoted by Reuters.

Sanofi said, the most common side effects associated with Aubagio include increased levels of the enyzme alanine transaminase, which can indicate damage to the liver, as well as hair loss, diarrhea, influenza, nausea and numbness of the skin.

FDA cautioned the doctors to test the liver function before prescribing the patients with Aubagio.