FDA OKs Sanofis' MS Drug Aubagio

(RTTNews.com) - The U.S. Food and Drug Administration Wednesday approved Sanofi's (SNY) multiple sclerosis drug Aubagio as a once daily tablet for the treatment of adults with relapsing forms of the disease.

In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo.

The drug contains a Boxed Warning to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment. Also included in the Boxed Warning is an alert noting that the drug may cause fetal harm.

The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss.

Multiple Sclerosis, or MS, is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods.

Meanwhile, European health officials are anticipated to decide on Aubagio in the first quarter of 2013.

SNY closed Wednesday at $43.26, up 0.19%, on a volume of about 3.2 million shares on the NYSE. In after hours, the stock gained 0.69%.

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FDA OKs Sanofis' MS Drug Aubagio