FDA Approves First Drug to Treat Aggressive MS.

**This is a synopsis of an article first published on STAT.

After a 40 year medical career dedicated to MS research, Dr. Stephen Hauser, director of the Weill Institute for Neurosciences at the University of California, San Francisco, has something to celebrate. Dr. Hauser’s breakthrough research has led to the creation and FDA approval of the first drug to treat primary-progressive (aggressive) MS.

Roche Holding AG (a Swiss drugmaker) announced that the FDA has approved the drug, ocrelizumab, responsible for blocking immune system cells called B cells. This drug differs from the other MS drugs on the market, which only target the system’s T cells (previously thought to be the cause of MS). Ocrelizumab will be marketed under the brand name Ocrevus. 

The approval of ocrelizumab was based on the results of a 732 patient clinical trial sponsored by Roche. The patients who took ocrelizumab were 25 percent less likely to experience worsening of their condition. The FDA also approved the drug for “relapse-remitting” forms of MS, i.e., inflammatory attacks that cause vision deterioration, tingling and weakness in the limbs, and mental confusion. 

The cost of ocrelizumab is set at $65,000 per year, which includes bi-annual infusions. The annual cost of ocrelizumab falls in between Rebif (clinically proven less effective than ocrelizumab), costing $86,000 per year and other MS drugs, costing $50,000 and above per year. 

MS is an autoimmune disease; the immune system attacks the body’s own healthy tissue. It is unknown what causes the immune system to turn on the body. For most individuals with MS, the myelin sheaths that protect the nerves and the transmission system that sends signals from the brain to the body become inflamed. The disease is diagnosed in patients between the ages of 20 and 40 years old and is most common in women. 

 “It’s the most common neurologic crippler of young adults,” Dr. Hauser said.

400,000 Americans and more than 2 million patients worldwide are suffering from Multiple Sclerosis (MS). Aggressive MS accounts for 10 to 15 percent of all MS cases. Symptoms of progressive MS include  “gradual worsening” of neurological symptoms that cause difficulty walking and in some patients, paralysis below the waist. 

Through decades of research, Dr. Hauser has proven that T cells aren’t solely responsible for the disease. It is a team effort between T cells and B cells. It is unclear exactly how they interact, but Dr. Hauser thinks that the B cells are “orchestrating the process by which T cells do their damage.”

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