U.S. FDA Approves Ocrevus (Ocrelizumab) to Treat Multiple Sclerosis
Author: U.S. Food and Drug Administration (FDA) - Contact: fda.gov
Published: 2017/03/30
Topic: FDA News and Approvals (Publications Database)
Page Content: Synopsis Introduction Main Item
Synopsis: Ocrevus (ocrelizumab) has been approved to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).
Introduction
On March 28, 2017, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) 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.
Main Item
"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."
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 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.
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.
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 most common side effects in the study of PPMS 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.
The FDA granted approval of Ocrevus to Genentech, Inc.
Explore Similar Topics
1 - Cognoa ASD Diagnosis Aid Approved for Marketing by FDA - Cognoa ASD Diagnosis Aid is an aid for diagnosis of ASD in patients 18 months - 5 years of age who are at risk of developmental delay based on concerns of a parent, caregiver, or health care provider.
2 - Neurolutions IpsiHand Upper Extremity Rehabilitation System - U.S. FDA authorizes marketing of Neurolutions IpsiHand Upper Extremity Rehabilitation System to facilitate muscle rehabilitation in stroke patients.
3 - Safety and Effectiveness of Consumer Hand Sanitizers - U.S. FDA completes series of actions on review of OTC antiseptic active ingredients and issues final rule on safety and effectiveness of consumer hand sanitizers.
Complete Publications Database
Page Information, Citing and Disclaimer
Disabled World is a comprehensive online resource that provides information and news related to disabilities, assistive technologies, and accessibility issues. Founded in 2004 our website covers a wide range of topics, including disability rights, healthcare, education, employment, and independent living, with the goal of supporting the disability community and their families.
Cite This Page (APA): U.S. Food and Drug Administration (FDA). (2017, March 30). U.S. FDA Approves Ocrevus (Ocrelizumab) to Treat Multiple Sclerosis. Disabled World. Retrieved December 1, 2024 from www.disabled-world.com/medical/pharmaceutical/fda/ocrevus.php
Permalink: <a href="https://www.disabled-world.com/medical/pharmaceutical/fda/ocrevus.php">U.S. FDA Approves Ocrevus (Ocrelizumab) to Treat Multiple Sclerosis</a>: Ocrevus (ocrelizumab) has been approved to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).
While we strive to provide accurate and up-to-date information, it's important to note that our content is for general informational purposes only. We always recommend consulting qualified healthcare professionals for personalized medical advice. Any 3rd party offering or advertising does not constitute an endorsement.