Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority of people with MS have a relapsing form or primary progressive MS at diagnosis.
MS is a neurological and autoimmune disease (where the body’s immune cells attacks its own healthy tissues), where the myelin sheath that insulates the nerve cells in the brain and spinal cord are degraded, resulting in a range of signs and symptoms, including physical, mental, and sometimes psychiatric problems. Primarily, it disrupts the communication between the brain and the body and leads to paralysis and mobility issues, gradually leading to worsening of neurological symptoms.
In primary progressive MS, the symptoms of MS gradually worsen from the start and there are usually no periods when symptoms subside. However, the more common type is the relapsing-remitting type of MS, in which the symptoms can wane for months, even years between flare-ups.
The decision to approve the drug for primary progressive MS was based on a Roche-sponsored clinical trial involving 732 patients, in which they found that patients on the drug were about 25% less likely to have their condition worsen when compared to the dummy infusions.
Even though 14 drugs have been approved till now for the most common type of MS, there has been no progress on drugs against primary progressive MS, said Lublin, a consultant to Genentech who was on the committee overseeing the study.
The new drug approved, Ocrelizumab, was based on the research done by Dr. Stephen Hauser, who is currently the Director of the Weill Institute for Neurosciences at the University of California, San Francisco. 40 years ago, when a young woman stepped into his office with this debilitating condition, Dr Hauser, a young doctor back then, was devastated. The disease seemed impossible to treat back then and that’s when he decided to pursue research on MS.
When most of the drugs in the market for MS targetted the T cells in the body, which was deemed as the main culprit, Dr Hauser’s research proved that B cells played a critical role in the disease and blocked these immune cells.
On hearing about the approval, Dr Hauser remarked, “It’s personally incredibly rewarding. This is a big deal for people with MS.”
Says Dr. Billy Dunn, director of the FDA’s Division of Neurology Products in a statement. “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.”
“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,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.
“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.”
- Genentech, part of Swiss drugmaker the Roche Group announced that OCREVUS™ is the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis.
- The drug is given intravenously every six months and the initial list price without insurance will be $65,000 a year.
- Patients receiving Ocrevus infusions had slower declines in walking ability and slower disability progression over nearly 2 ½ years, as compared to dummy infusions.
- In two other major studies involving about 1,656 patients, the drug was assessed for the treatment of relapsing forms of MS. In those 96-week studies, patients receiving Ocrevus had lower relapse rates and reduced worsening of disability compared to participants given Rebif, a standard drug for relapsing MS, according to the FDA.
- Ocrevus will be available in the U.S. within two weeks