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FDA approves new multiple sclerosis medication Ocrevus




A new drug to treat adult patients suffering from primary progressive multiple sclerosis (PPMS) has been approved by the US Food & Drug Administration (FDA). Ocrevus (ocrelizumab) was developed by Genentech - a member of the Roche Group - and will be available to patients across the United States within a week. It is the first FDA-approved therapy available to PPMS sufferers, a condition diagnosed at onset in approximately 10 percent of multiple sclerosis (MS) patients.  

Commenting on the approval of Ocrevus, June Halper, MSN, APN-C, MSCN, FAAN and chief executive officer at the Consortium for MS Center, said: “This is an exciting day for everyone touched by MS.” It was a “source of hope” for many people living with the disease, she added. Her views were echoed by Billy Dunn, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, who observed: “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 PPMS.” 

MS is a chronic autoimmune disease affecting the central nervous system, leading to increased disability and a decline in mobility. The Multiple Sclerosis Foundation estimates more than 400,000 people in the US have MS, with approximately 200 new cases diagnosed every week. The cause is still uncertain, but research has revealed a number of risk factors. Women are more susceptible, with twice as many female patients with MS as there are male. Of those diagnosed with the condition, around 15 percent have one or more family members or relatives with MS, according to the National Institute of Neurological Disorders and Stroke. Patients with type 1 diabetes, thyroid disease or inflammatory bowel disease are also at a higher risk of developing MS. 

PPMS is considered one of the most disabling forms of MS, and until now there has been no FDA-approved disease-modifying therapy. Ocrevus is an intravenous infusion administered by a healthcare professional and its effectiveness was shown in two clinical trials. These demonstrated Ocrevus’s significantly superior efficacy over a beta interferon drug in three major markers of PPMS. It reduced annual relapses by almost half and noticeably slowed progression of disability among patients. The new drug also significantly reduced MRI lesions over a two-year controlled period. The most notable side effects of Ocrevus were infusion reactions and minor to moderate upper respiratory tract infections.

Ocrevus is the first FDA-approved therapy for PPMS, but other prescription drugs and treatments to alleviate symptoms associated with MS attacks are available. Corticosteroids, such as oral prednisone, are often prescribed to reduce inflammation of the nerves. Relapsing-remitting MS medication options include beta interferons, glatiramer acetate (Copaxone), fingolimod (Gilenya) and dimethyl fumarate (Tecfidera). Muscle relaxants such as baclofen (lioresal) or tizanidine (Zanaflex) may also be prescribed to reduce pain, muscle stiffness and spasming. Patients with MS may also benefit from physical or occupational therapy sessions to improve mobility, strength and flexibility.  

For more information on Ocrevus: 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549325.htm

https://www.gene.com/media/press-releases/14657/2017-03-28/fda-approves-genentechs-ocrevus-ocrelizu