FDA Approves First Drug for Severe Form of Multiple Sclerosis

FDA Approves First Drug for Severe Form of Multiple Sclerosis

Ocrevus (ocrelizumab) is the first drug approved for the treatment of primary progressive multiple sclerosis.

Last week the FDA approved the drug Ocrevus (ocrelizumab) to treat adults with severe forms of multiple sclerosis (MS), a disabling disease in which the immune system attacks the protective coating around the nerves.

This is the first medication given the OK to treat primary progressive multiple sclerosis (PPMS), a rarer form of MS that makes up about 15 percent of diagnoses. People with PPMS experience progressively worsening neurological function from symptom onset, typically without remission or relapse. For people with relapsing forms of multiple sclerosis, ocrelizumab provides another treatment option.

A new treatment offers some hope
"We've been banging on a wall with a bunch of drugs, and we finally put a big crack in the wall," Jerry Wolinsky, MD, professor emeritus at the University of Texas Health Science Center at Houston, told CNN. Dr. Wolinsky was a lead author for The New England Journal of Medicine study that showed ocrelizumab slowed the progression of PPMS.

Ocrelizumab is administered through an intravenous infusion every six months. The drug blocks B cells, immune system cells that play a big part in the condition. This differs from other MS drugs on the market, which target T cells, thought to be another critical contributor to MS.

For the treatment of PPMS, Ocrevus was tested in 732 people for at least 120 weeks. People who received Ocrevus were slower to decline into worsening disability when compared to placebo. For the treatment of relapsing forms of MS, Ocrevus was tested in two clinical trials. A total number of 1,656 people were treated with either Ocrevus or another MS drug, called Rebif, for 96 weeks. In both trials, Ocrevus reduced both relapse rates and progression of disability when compared to Rebif.

The drug should be available to people within the next few weeks. Some side effects related to infusion administration include itchy skin, rash or redness. Upper respiratory infection was another reported side effect. There were also serious side effects associated with the drug like that it could lead to an increased risk of cancer or cause hepatitis B to reactivate in people who have the infection.

Multiple sclerosis, explained
MS is a devastating autoimmune disease affecting about 2.3 million people worldwide. It occurs when the immune system attacks the protective coating, called myelin, surrounding the nerve fibers in the brain and spinal cord. Damage to the myelin causes communication problems between the brain and the body. Over time, as the disease progresses, the nerves can deteriorate or become permanently damaged. Typical MS symptoms include fatigue, difficulty walking, involuntary muscle spasms or spasticity, cognitive impairment, depression and vision problems.

While the cause of MS is unknown, there are some factors that may increase your risk. MS most commonly affects people between ages 20 and 40. Women are also more likely to develop the disease. If you have a parent or sibling with MS, you might also be at increased risk.

For people with PPMS, who tend to experience severe neurological impairment without remission, this newly approved treatment provides some hope.

Medically reviewed in November 2018.

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