The FDA ( U.S. Food and Drug Administration ) has approved Ocrevus ( Ocrelizumab ) to treat adult patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis ( PPMS ).
This is the first drug approved by the FDA for PPMS.
Ocrevus is an intravenous infusion given by a health care professional.
Multiple sclerosis 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 multiple sclerosis, 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 multiple sclerosis between the ages of 20 and 40.
Primary progressive multiple sclerosis 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 ( CDC ) estimates that approximately 15% of patients with multiple sclerosis have primary progressive multiple sclerosis.
The efficacy of Ocrevus for the treatment of relapsing forms of multiple sclerosis was shown in two clinical trials in 1,656 participants treated for 96 weeks. Both studies compared Ocrevus to another 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 primary progressive multiple sclerosis 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.
In addition to the infusion-related reactions, the most common side effect of Ocrevus seen in the clinical trials for relapsing forms of multiple sclerosis was upper respiratory tract infection.
The most common side effects in the study of primary progressive multiple sclerosis were upper respiratory tract infection, skin infection, and lower respiratory tract infection.
The FDA granted this application breakthrough therapy designation, fast track designation, and priority review. ( Xagena )
Source: FDA, 2017