The U.S. FDA has authorized Ocrevus (ocrelizumab) as a treatment for patients with relapsing multiple sclerosis (MS). MS is an autoimmune condition that targets the central nervous system. Its chronic inflammation alters communications between the brain and the body. It is the most common neurological disorder in young adults. Occurring more frequently in women, it delivers a series of painful relapses and remissions. As time progresses, recovery no longer becomes an option and the disability leaves a haunting effect on the body.
There are already several treatments for MS but the FDA gave Ocrevus a breakthrough therapy designation, a fast track designation and a priority review.
Effective since March 28, 2017 the FDA favored the Drug because it also treats primary progressive MS (PPMS). This is when the disease gradually worsens omitting episodes of relapse or remission. Made by Genentech, the intravenous solution is the first drug ever to be considered effective treatment for people with PPMS.
Clinical trials
The effectiveness of ocrelizumab was tested in several different studies surrounding the multiple forms that MS has. One study involved 1,656 patients being treated with the drug over a course of 24 months. Another consisted of 732 participants being administered the breakthrough medication for a minimum of 30 weeks. Both studies concluded that this medicine reduced relapses and prevented the condition from worsening.
Doctors throughout the United States have expressed their gratitude in the remarkable discovery of the drug. Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research is one of them. He’s said, “Multiple Sclerosis can have a profound impact on a person’s life. This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”
Another physician amazed by this groundbreaking drug is Dr.
Dhanashri Miskin, neurologist at New York City’s Lenox Hill Hospital. He stated, “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.”
Pricing and availability
Genentech has reported that it will list Ocrevus at $65,000 per year before insurance.
The company, owned by Roche in Switzerland, has yet to respond to any pricing requests.
Genentech said in a statement that it’s attempting to challenge current MS-drug prices since insurance companies often require patients to complete step-care therapy before trying a new drug. MS patients may have a greater advantage when it comes to being approved for Ocrevus since it’s the only drug out right now used to treat PPMS.
There’s an estimated 2 million people worldwide living with some form of multiple sclerosis. Common symptoms are pain, cramping, muscle weakness, changes in vision, impaired movement, extreme fatigue and numbness.
Genentech announced that Ocrevus will be made available in the U.S. with the next two weeks.
