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St. Michael’s scientists helped to develop new oral drug approved by FDA that reduces relapses in multiple sclerosis patients

Toronto, September 13, 2012

By Leslie Shepherd

Patient blood management - blood bags
Dr. Paul O’Connor

Scientists at St. Michael’s Hospital helped to develop a new oral drug that reduces relapses in multiple sclerosis patients and slows the progression of the disease.

The U.S. Food and Drug Administration this week approved teriflunomide for use in the United States, starting around Oct. 1. The drug is manufactured by Genzyme, a Sanofi company, under the brand name Aubagio.

The clinical trials for the drug were led by Dr. Paul O’Connor, director of the Multiple Sclerosis Clinic at St. Michael’s Hospital in Toronto, the largest and one of the most active MS research clinics in Canada.

Multiple sclerosis is the most common disabling neurological disorder of young adults in Canada. In this condition, the immune system attacks the myelin sheath surrounding nerve cells. MS has traditionally been treated with injectable drugs, which are uncomfortable to use and have side effects.

Only one other oral medication for MS has been approved by Health Canada and the FDA. Dr. O’Connor said he hoped Aubagio, a once-a-day tablet, would be approved for use in Canada next year.

“The approval of this oral drug for MS patients who have relapsing disease is a very welcome addition to the other drugs currently available to treat this disabling illness,” Dr. O’Connor said.

The clinical trials for which Dr. O’Connor was the principal investigator involved 1,088 MS patients in 127 centres in 21 countries who had at least one relapse in the previous year or at least two relapses in the previous two years. A relapse is either the appearance of a new symptom of the disease – such as weakness, numbness, loss of vision -- or a worsening of previous symptoms that had been stable.

The results of the Phase 3 clinical trial published in the New England Journal of Medicine in October 2011 found a 31-per-cent reduction in relapses in patients taking the drug – 31.2 per cent for those taking 7mg and 31.5 per cent for those taking 14 mg.

The drug also increased the length of time before a patient relapsed and more patients taking it remained free of relapses. Progression of the disease was also reduced by almost 30 per cent among those taking the 14-mg dose.

Aubagio works by attaching itself to an enzyme that is important for the synthesis of DNA. That prevents rapidly dividing cells in the immune system from dividing and attacking the central nervous system.

The most common side effects experienced by participants in clinical trials include diarrhea, abnormal liver tests, nausea, flu and hair thinning.

About St. Michael’s Hospital

St. Michael’s Hospital provides compassionate care to all who enter its doors. The hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital’s recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing International Healthcare Education Center, which make up the Li Ka Shing Knowledge Institute, research and education at St. Michael’s Hospital are recognized and make an impact around the world. Founded in 1892, the hospital is fully affiliated with the University of Toronto.