Type Whole antibody Target CD20 ATC code L04AA36 (WHO) | Source Humanized (from mouse) Routes of
administration Intravenous infusion Legal status Investigational | |
Ocrelizumab is a humanized anti-CD20 monoclonal antibody. It targets CD20 marker on B lymphocytes and hence is an immunosuppressive drug candidate. It is under development as a treatment for multiple sclerosis by Hoffmann–La Roche's subsidiary Genentech.
Contents
Ocrelizumab is a slightly modified version of Biogen/Genentech's existing therapy Rituxan/Rituximab. Because Ocrelizumab's patent was granted later, the company switched its efforts from Rituxan to the modified drug, extending the period for which it could market a patent-protected form of the therapy. It halted its Rituxan trials and began trials with Ocrelizumab.
Clinical trials
It reached Phase III clinical trials for rheumatoid arthritis and lupus erythematosus and Phase II for multiple sclerosis (MS) and hematological cancer.
In March 2010, Roche announced the suspension of clinical trials in rheumatoid arthritis and lupus erythematosus. This step followed excess deaths due to opportunistic infections. Development for multiple sclerosis continued.
Multiple sclerosis
In October 2010, Roche announced 24-week results from the PhII study in relapsing-remitting MS. The drug demonstrated a statistically significant reduction in disease activity as measured by brain lesions (measured by MRI scans) and relapse rate compared to placebo. Both doses (200 mg and 600 mg) were well tolerated [Ref?].
On October 9, 2015, Genentech presented interim results of three Phase III clinical trials that look promising. Progression of disability was reduced at 12 and 24 weeks.
On February 17, 2016 Food and Drug Administration granted Breakthrough Therapy Designation for primary progressive multiple sclerosis