Navigation Links
FDA approves new drug to treat multiple sclerosis
Date:3/29/2017

SILVER SPRING, Md., March 29, 2017 On March 28, 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. 

"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.

Additional information:
National Institute of Neurological Disorders and Stroke: Multiple Sclerosis, Hope Through Research 
FDA Approved Drugs: Questions and Answers 
Novel Drug Approvals for 2017

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-approves-new-drug-to-treat-multiple-sclerosis-300431072.html


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2017 PR Newswire.
All rights reserved


Related medicine technology :

1. FDA APPROVES APTIMA HPV ASSAY FOR USE ON HOLOGICS PANTHER SYSTEM
2. FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults
3. FDA approves drug tested by Scottsdale Healthcare and TGen
4. FDA Approves Aptima HPV 16 18/45 Genotype Assay for Use on Hologics Panther System
5. PMDA Approves Jarvik 2000 Heart in Japan
6. Cardinal Health Board of Directors Approves Quarterly Dividend, Authorizes Increase to Share Repurchase Program, Announces Board Leadership Changes
7. FDA Approves Pembrolizumab for Advanced Melanoma
8. FDA approves PleximmuneTM for personalized prediction of transplant rejection in children
9. FDA Approves VisionCares Telescope Implant for Macular Degeneration in Patients 65 Years and Older
10. FDA Approves Investigational Study for New Smaller SynCardia Total Artificial Heart
11. European Regulatory Authority Approves Clinical Investigators Request for Compassionate Use with Omeros Corporations OMS721
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/16/2017)... June 16, 2017  Exactly 50 years ago today, the ... later became known as the San Francisco "Summer of Love."  ... unveiling two radical innovations in strategic market research portals that ... marks the beginning of Northern Light,s "Summer of Love (For ... ...
(Date:6/14/2017)... June 14, 2017  In 2016, Embodied Labs ... pitch competition and came away with $25,000 in ... described by Forbes as "entering the life of another" ... as teaching "empathy to medical professionals in an entirely ... recently named a finalist for the Department of Education,s ...
(Date:6/11/2017)... INDIANAPOLIS , June 10, 2017  Eli Lilly and ... results from three Phase 3 studies of galcanezumab, an ... migraine, including late-breaking data on several key secondary endpoints ... Detailed results from these studies (EVOLVE-1, EVOLVE-2 and REGAIN) ... (AHS) annual scientific meeting in Boston ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... 23, 2017 , ... Military Connection friend and veteran advocate Micaela ... Virgin Atlantic lounge. , Bensko is no stranger to the plight of the ... her life to supporting our wounded veterans. A world-class photographer, her riveting photos “The ...
(Date:6/23/2017)... ... 23, 2017 , ... The Aesthetic Channel has recently highlighted Dr. Ben Talei’s ... with a proprietary technique that he calls the AuraLyft Facelift. The AuraLyft ... ages, patients can expect to look refreshed, rejuvenated, and revitalized. , Dr. Talei’s ...
(Date:6/23/2017)... ... ... 21 Middle East and South Asia Leaders Selected as Eisenhower Fellows , ... in 11 countries across the Middle East and South Asia to embark on a ... and ideas with the leading minds in their fields. , For the first ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ross Insurance Agency ( http://www.rossinsuranceagency.com ... Emergency Management Agency’s (FEMA) recent update of flood zones, more people than ever ... Act was enacted to reflect the actual risk in flood zone areas during ...
(Date:6/23/2017)... ... June 23, 2017 , ... The Katyl ... services to families and business owners in and around Lackawanna County, is joining ... citizens in the area. , Meals on Wheels of NEPA provides hand-delivered and ...
Breaking Medicine News(10 mins):