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Drug maker Sanofi wins backing to sell MS pill

By Catholic Online (NEWS CONSORTIUM)
September 13th, 2012
Catholic Online (www.catholic.org)

A medication intended to help those suffering from multiple sclerosis, or MS, entitled Aubagio will soon be on the market. This comes as welcome news to drug maker Sanofi, as it will put them on a multi-billion dollar playing field. Medical officials wish to remind others that Aubagio is not as effective as other drugs intended to treat MS.

LOS ANGELES, CA (Catholic Online) - Meant to be administered once a day, the Food and Drug Administration approved the medicine for relapsing forms of the debilitating disease. Aubagio goes under the scientific name of teriflunomide and is for patients in the initial phases of the disease, the Paris-based Sanofi said.

Sales may be limited because the drug isn't as effective as Novartis AG's Gilenya, the first MS pill approved in Europe, or Tysabri from Elan Corp. and Biogen Idec Inc. Biogen's oral drug BG-12 also may also shortly win U.S. approval by the end of the year.

Aubagio "has clear limitations," doctors write. "We doubt the drug will seriously affect Gilenya or Tysabri, where prescriptions are largely driven by efficacy."

According to estimates compiled by Bloomberg, the treatment may garner annual sales of $330 million in 2016.

Genzyme executives say that the treatment will be an important option for many MS patients.

Aubagio's safety is "very well characterized," and the medicine "is in a different place, targeting a different patient population" from Gilenya. Michael Panzara, Genzyme's therapeutic area head for multiple sclerosis and immune diseases says that Gilenya has "an evolving safety profile, which we continue to learn about every day," he said.

Multiple sclerosis is characterized by an abnormal immune response that attacks the protective covering that surrounds nerve cells in the brain and spinal cord. Nerve cells are prevented from sending signals, sapping patients' energy, blurring their vision and slowly robbing them of mobility, balance and coordination.

Patients using Aubagio had a release rate of about 30 percent lower than the rate for those taking a placebo. The drug will carry a boxed warning about the risk of liver toxicity and birth defects.

Much more common in women than in men, multiple sclerosis is believed to affect more than 2.1 million people worldwide. Many patients have trouble staying on current therapies as the drugs are difficult to use or cause side effects.

Aubagio will cost $45,000 a year in the U.S., 28 percent less than Gilenya. The lower price is due to the fact that Aubagio is less effective than the Novartis product and carries the risk of liver side effects.

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