New Multiple Sclerosis Specialty Therapy Offers Hope for Patients
In late March, the U.S. Food & Drug Administration (FDA) approved Ocrevus™ (ocrelizumab), a new specialty medication from Genentech, Inc., for the treatment of primary progressive multiple sclerosis (PPMS). It was also approved to treat the more common relapsing remitting MS (RRMS) and, in both cases, had very few side effects.
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According to an FDA news release, the new intravenous infusion is the first approved therapy for PPMS, which afflicts approximately 15% of MS patients. In clinical trials, Ocrevus slowed the progression of PPMS. However, for those with RRMS, the results were even more promising. According to a Genentech news release, Ocrevus “demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half, slowing the worsening of disability, and significantly reducing MRI lesions.” The most common side effects associated with the drug were infusion reactions and upper respiratory tract infections, most of which were mild to moderate.
Although the new medication showed only modest benefits for those with PPMS, Genentech’s researchers say it’s a step in the right direction and paves the way for greater understanding and more treatment options for the more disabling of the two conditions. Based on preclinical studies, the drug, which is a humanized monoclonal antibody, works by binding to CD20 cell-surface proteins expressed on certain B cells but not on stem cells or plasma cells.
Genentech reports that it expects to begin selling Ocrevus in the U.S. in the next week or so at a list price of $65,000. The drug is administered as an infusion every 6 months, starting with a first dose of two 300-mg infusions two weeks apart. That’s followed by biannual 600-mg infusions. Genentech, which is owned by Swiss drugmaker Roche, said it plans to offer patient assistance programs through Genentech Access Solutions for those who qualify.
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