Patients suffering from cases of severe multiple sclerosis (MS) received great news in the form of a new drug approval by the US Food and Drug Administration. The new medication offers hope for the most severe form of the progressive disease.
Multiple sclerosis is an autoimmune disease where the body’s immune system mistakenly attacks itself. It is estimated that more than 400,000 people in the U.S. currently have MS, with roughly 15 percent having the progressive form. MS symptoms include—but are not limited to—visual disturbances, muscle weakness, trouble with coordination and balance, and memory problems.
The new drug is called ocrelizumab (Ocrevus) and is made by Genentech. it is an intravenous drug that is given every six months. It was specifically formulated for patients with relapsing multiple sclerosis (MS)—the most common form of the disease, the FDA reported. This new drug also appears to slow progression of a more severe type of the disease, called primary progressive MS.
“If the side effect profile continues to hold up … I think ocrelizumab will become the leading MS therapy,” said Dr. Steven Galetta, who wasn’t involved in the clinical trials that led to the drug’s approval. “The drug offers the first option for patients with primary progressive MS,” he added. “However, side effects need to be monitored going forward. Of particular concern are infections and tumors.”
Other neurologists have spoken up in collective agreement.
“In clinical trials, ocrelizumab showed promising results in slowing the disease activity of primary-progressive multiple sclerosis, as well as the more common, relapsing-remitting form of MS,” said Dr. Dhanashri Miskin, attending neurologist at Lenox Hill Hospital in New York City.
“The side effects also appear to be more reasonable compared to other drugs currently available. We still need to be cautious about the potential long-term safety of the drug once it is widely prescribed,” Miskin added.
Dr. Fred Lublin, an investigator for the clinical trial, told The Times: “This sort of opens the door for us. Once we open that door, then we do better and better and better.”
The FDA approval followed two clinical trials. One involved more than 700 patients with progressive multiple sclerosis, with researchers finding that those taking Ocrevus had 24 percent less risk of their disability progressing versus patients who were taking a placebo.
The other trial involved patients with relapsing MS and saw a 47 percent reduction in their rate of relapse when taking Ocrevus, opposed to patients taking Rebif, another form of MS treatment.