There is some very good news for sufferers of multiple sclerosis (MS) with the FDA announcing it has approved a new drug to treat adults with relapsing forms of the MS and primary progressive multiple sclerosis (PPMS), making it the first drug approved for PPMS. The drug, Ocrevus (ocrelizumab), is delivered through intravenous infusion.
“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “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 the FDA, MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people experience their first symptoms of MS between the ages of 20 and 40.
PPMS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions. The U.S. Centers for Disease Control and Prevention estimates that approximately 15 percent of patients with MS have PPMS.
“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 for Genentech – the developer of the drug. “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.”
Ocrevus was proven as an effective treatment in two clinical trials including 1,656 people treated for 96 weeks. Both studies compared Ocrevus to another MS drug, Rebif (interferon beta-1a). In both studies, the patients receiving Ocrevus had reduced relapse rates and reduced worsening of disability compared to Rebif.
In a study of PPMS in 732 participants treated for at least 120 weeks, those receiving Ocrevus showed a longer time to the worsening of disability compared to placebo.
Ocrevus should not be used in patients with hepatitis B infection or a history of life-threatening infusion-related reactions to Ocrevus. Ocrevus must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Ocrevus can cause infusion-related reactions, which can be serious. These reactions include, but are not limited to, itchy skin, rash, hives, skin redness, flushing, low blood pressure, fever, tiredness, dizziness, headache, throat irritation, shortness of breath, swelling of the throat, nausea, and fast heartbeat. Additionally, Ocrevus may increase the risk for malignancies, particularly breast cancer. Delay Ocrevus treatment for patients with active infections. Vaccination with live or live attenuated vaccines is not recommended in patients receiving Ocrevus.
The most common side effects associated with OCREVUS in all Phase III studies included infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Results from these three Phase III studies were recently published in the January 19, 2017 issue of the New England Journal of Medicine (NEJM).
“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,” said June Halper, MSN, APN-C, MSCN, FAAN, chief executive officer at the Consortium for MS Centers. “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.”