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Home Drug Development FDA Approvals

Roche to present new data at AAN reinforcing efficacy and safety of newly FDA-approved OCREVUS

Yuvraj_pawp by Yuvraj_pawp
19th April 2017
in FDA Approvals

Roche announced that new data on OCREVUS™ in people with relapsing forms of multiple sclerosis (RMS) and primary progressive MS (PPMS) will be presented during the 69th American Academy of Neurology (AAN) Annual Meeting from 22 to 28 April in Boston, Massachusetts.

Data presented across three platform sessions will describe the rapid benefit of OCREVUS in RMS patients in the first eight weeks of treatment and its effect on fatigue in PPMS patients. Efficacy and safety data from the open-label extension study will also be presented, as well as the effect of OCREVUS on active disease and progression in PPMS.

“OCREVUS is the only disease-modifying therapy approved by the FDA for people with primary progressive MS and offers people with relapsing MS a new treatment option with a favourable benefit-risk profile”, said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The data being presented at AAN will demonstrate how rapidly OCREVUS controls disease activity and reduces brain MRI lesions in people with early RMS, both of which are important goals of treatment.’’


Leading investigators will present the following oral and poster presentations:


Full session details and data presentation listings for the 2017 AAN Annual Meeting can be found at the meeting website: https://www.aan.com/conferences/2017-annual-meeting/


OCREVUS received approval from the U.S. Food and Drug Administration (FDA) on 28 March 2017 for the treatment of adult patients with relapsing or primary progressive forms of MS.


About OCREVUS™ (ocrelizumab)
OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

OCREVUS is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

About Roche in neuroscience
Neuroscience is a major focus of research and development at Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims for improving patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com

 

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