Tuesday, March 28, 2017

New MS Drug Ocrevus Wins FDA Approval

by Anthony Serritella and Rehema Ellis
Mar. 28, 2017

The Food and Drug Administration approved a new drug to treat multiple sclerosis Tuesday.

The drug, called Ocrevus, is approved for use against the most common form of MS - the relapsing-remitting type. It's also approved for primary progressive MS, a very aggressive form of the disease that affects 10 to 15 percent of MS patients.

There are no approved treatments now for primary progressive MS, which causes steadily worsening symptoms.

While it's not a cure, it's one more weapon to use to help some of the 400,000 people with MS. In trials of 1,600 volunteers, it cut relapses in patients with the most common form of MS by nearly half compared with an older drug called Rebif.


While there are many drugs in the highly competitive MS market, Cyndi Zagieboylo, president and CEO, of National MS Society, says there is room for improvement. Many of the drug suppress the immune system, have dangerous side-effects and often do not change the course of the disease.


Ocrevus can cause serious side-effects, such as an increased risk of infections and cancer, notably breast cancer. About one-half of one percent of the patients who took the drug developed cancer, which was twice the rate of those who did not take the drug.

In 2010, Roche and Biogen suspended trials of the drug in patients with against rheumatoid arthritis after some died from infections that became serious because of the drug's immune-suppressing effects.

Roche says those problems did not come up in the MS trials. Hauser says doctors may need to wait for studies that Roche must conduct in larger populations of patients who take the drug after it's approved.


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