The U.S. Food and Drug Administration approved a new drug called Ocrevus (ocrelizumab) this week to treat adults with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug for PPMS to be approved by the FDA.
Ocrevus is an intravenous infusion given by a healthcare professional. It is expected to be available for administration to patients by early May.
"The FDA approval of Ocrevus brings the number of available treatments for relapsing forms of MS to 17," said Ben Thrower, MD, medical director of the Andrew C. Carlos MS Institute at Shepherd Center. "However, it represents the first FDA-approved therapy for PPMS. This is truly exciting."
Shepherd Center was one of the clinical trial sites for Ocrevus. Clinical researchers saw no significant reactions or side effects in the patients enrolled in the study at Shepherd Center, Dr. Thrower noted.
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 efficacy of Ocrevus for the treatment of relapsing forms of MS was shown in two clinical trials in 1,656 participants 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.
The FDA noted in its announcement that Ocrevus should not be used in patients with hepatitis B infection or a history of life-threatening infusion-related reactions to Ocrevus. 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, the FDA said. Additionally, Ocrevus may increase the risk for malignancies, particularly breast cancer. Physicians should delay Ocrevus treatment for patients with active infections. Vaccination with live or live attenuated vaccines is not recommended in patients receiving Ocrevus.
In addition to the infusion-related reactions, the most common side effect of Ocrevus seen in the clinical trials for relapsing forms of MS was upper-respiratory tract infection, the FDA said. The most common side effects in the study of PPMS were upper-respiratory tract infection, skin infection and lower-respiratory tract infection.
The Andrew C. Carlos MS Institute at Shepherd Center treats more than 2,500 patients annually who have MS, suspected MS or related disorders. The MS Institute provides a wide range of treatment, rehabilitation and wellness services.
Healthcare professionals in the MS Institute believe early and appropriate treatment results in a better quality of life for people with MS and may protect against future illness. Clinicians work aggressively to slow the progression of the disease. To learn more about the MS Institute, visit Shepherd’s website.
For more information on Ocervus, visit the FDA website.
Shepherd Center, located in Atlanta, Ga., is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury or brain injury. Founded in 1975, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation and is a 152-bed facility. Last year Shepherd Center had 965 admissions to its inpatient programs and 571 to its day patient programs. In addition, Shepherd Center sees more than 6,600 people annually on an outpatient basis. For more information, visit Shepherd Center online at www.shepherd.org