Study of Potential Therapy for Relapsing MS That Targets B-Cells Now Recruiting Patients in US

Patients with relapsing multiple sclerosis (MS) are being recruited for a clinical trial evaluating an experimental monoclonal antibody called ublituximab, the National MS Society announced in a recent news release. The study, being conducted at seven U.S. sites, will enroll at least 24 patients, but this number can go up to 100. MS is considered to be…

ICER Draft Report Evaluating Therapies for RRMS Now Open for Public Comment

The Institute of Clinical and Economic Review (ICER) released the early draft of a paper intended to inform a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called a draft scoping document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and…

1st Potential Therapy for Primary Progressive MS, Ocrelizumab, Under Priority Review by FDA

The U.S. Food and Drug Administration (FDA) is giving priority review to a request to approve Ocrevus (ocrelizumab) as a treatment for both forms of multiple sclerosis, the drug’s developer, Genentech, announced. If the company’s Biologics License Application (BLA) is approved, Ocrevus will become the first drug able to treat patients with either relapsing or…

#CMSC16 – Ocrevus (Ocrelizumab) in PPMS Prevented Disability Progression, Lowered MRI Lesion Volume, Study Shows

Data recently presented at the Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual Meeting showed that Roche/Genentech’s investigational drug ocrelizumab (Ocrevus) lowered the risk of disability progression in primary progressive multiple sclerosis (PPMS), a condition for which no approved treatments exist. The study was presented during the “…

#CMSC16 – Genentech’s Ocrelizumab (Ocrevus) a Promising Therapy for Primary Progressive MS; Interview with Lead Researcher

Genentech, a member of the Roche Group, was founded more than 35 years ago and has been focused on a variety of research fields, including cancer, immunology, neurodegenerative disorders, metabolic diseases, and infectious diseases. Genentech has been committed to discovering and developing new medicines for patients with major diseases of the nervous…

FDA Grants ‘Breakthrough Therapy’ Designation to Genentech’s Ocrelizumab for PPMS

Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment for primary progressive multiple sclerosis (PPMS), Breakthrough Therapy Designation based on positive Phase 3 clinical trial results showing that ocrelizumab significantly reduced disability progression and other disease activity markers compared to placebo. The FDA designation is…