Sanofi has obtained FDA approval  for its oral drug Aubagio® (teriflunomide). It is a prescription medicine used to treat relapsing forms of multiple sclerosis. Aubagio does not cure MS.

 

A representative for Sanofi

subsidiary Genzyme said “the treatment will be priced at $45,000 a year, angling in to grab market share.

"The price of Copaxone is 7% more," the price of Avonex is 8% more and the price of Gilenya is 28% more than the price of Aubagio." The new treatment was filed for approval by Sanofi's biologics arm, Genzyme.

 

"In a clinical trial, the relapse rate for people who have multiple sclerosis using Aubagio was about 30 percent lower than the rate for those taking a placebo," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Centre for Drug Evaluation and Research. "Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients."

In the Phase III "TOWER" study, people who have MS on a daily 14 mg dose of teriflunomide had a 36.3% drop in annualised relapse rate--which was the main goal of the study--compared with those taking a placebo. There was also a 31.5% drop in the risk of disability among patients on that dose of Genzyme's drug compared with placebo patients, the company reported that no new side effects cropped up in this trial that hadn't been seen before in previous studies?

The safety of oral MS drugs will need to be proven over time.

The drug contains a Boxed Warning to alert prescribers and patients to the risk of liver problems, including death, and a risk of birth defects. Health professionals 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, based on animal studies, the drug may cause foetal harm. For this reason, Aubagio is labelled as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment.