The U.S. Food and Drug Administration has given Roche’s multiple sclerosis drug ocrelizumab, brand name Ocrevus approval for the treatment of both relapsing and primary progressive forms of the disease.
Ocrelizumab is a humanized anti-CD20 monoclonal antibody which targets CD20 marker on B lymphocytes. It is a slightly modified version of Biogen/Genentech’s existing therapy Rituxan/Rituximab, developed by Hoffmann–La Roche’s subsidiary Genentech.
This marks the first and only approval of a treatment for primary progressive form of multiple sclerosis (PPMS), one of the most disabling forms of multiple sclerosis (MS).
Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development, said:
“The FDA’s approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B-cell targeted therapy. Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”
The approval was based on two identical RMS Phase III studies (OPERA I & OPERAII), demonstrating efficacy on three major markers of disease activity. Ocrelizumab reduced relapses per year by nearly half, slowing the worsening of disability and significantly reducing MRI lesions compared with high-dose interferon beta-1a (Rebif) over the two-year controlled treatment period.
Affecting about 10-20% of people diagnosed with MS, primary progressive MS is characterized by progression of disability from the onset, with no, or only occasional and minor, remissions and improvements.
A separate primary progressive MS Phase III study (ORATORIO), showed Ocrevus to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. A similar proportion of patients in the OCREVUS group experienced adverse events and serious adverse events compared with patients in the placebo group in the PPMS study.
“This is an exciting day for everyone touched by MS, a disease that strikes in the prime of a person’s life when she or he may be starting a career or family. We have eagerly awaited the FDA approval of OCREVUS because it not only offers a new, highly efficacious treatment option for people with relapsing multiple sclerosis, but it is also the first disease-modifying therapy indicated for primary progressive multiple sclerosis, a highly disabling type of this chronic disease. For many people living with MS, this FDA approval is a source of hope.”
OCREVUS is administered by intravenous infusion every six months. Genentech indicated it would carry a list price of $65,000 a year — 25 percent less expensive than Rebif, shown to be clinically inferior to Ocrevus in OPERA I & OPERA II.