Roche Group’s subsidiary Genentech has secured the US FDA approval for its multiple sclerosis drug, Ocrevus (ocrelizumab) for treating both relapsing and primary progressive variants of the chronic disease through intravenous infusion.
The FDA approval has made the Genentech MS drug Ocrevus as the first and only therapy available for the two forms of multiple sclerosis (MS) which is what most of the patients suffering from the disease have during diagnosis. It is also the first drug approved by the FDA for the treatment of Primary Progressive MS (PPMS).
Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research on the approval of Genentech MS drug Ocrevus 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.”
According to Genentech, Ocrevus MS drug will be rolled out in the US inside two weeks.
Commenting on the FDA approval of Genentech MS drug Ocrevus, Sandra Horning, M.D., the company’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.”
Two similar RMS Phase III studies by the names OPERA I and OPERA II proved the superior efficacy of Genentech MS drug Ocrevus on the three major markers of disease activity by cutting down relapses per year by almost half, decelerating the worsening of disability and considerably bringing down MRI lesions compared with Rebif (high-dose interferon beta-1a) during the controlled treatment period that lasted two years.
An identical portion of patients in the Ocrevus arm were observed to have a reduced rate of serious adverse events and serious infections compared with patients subjected to the high-dose interferon beta-1a, Rebif arm in the RMS trials.
In a separate PPMS Phase III trial dubbed ORATORIO, Genentech MS drug Ocrevus became the first and only treatment to slow disability progression considerably. It also lowered disease activity signs in the brain (MRI lesions) when compared with placebo with a three-year median follow-up.
An identical portion of patients in the Genentech MS drug Ocrevus arm were observed to have adverse events and a reduced rate of serious adverse events in the PPMS trial, when compared with patients in the placebo arm.