Roche’s Ocrelizumab Granted Priority Review
The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.
An investigational monoclonal antibody Ocrevus (ocrelizumab), developed to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), was granted Priority Review Designation by FDA on June 27, Genentech announced. The drug received Breakthrough Therapy status from FDA in February 2016. The priority designation will give the drug a target action date of December 28, 2016.
If approved, the drug would be the first and only treatment indicated for both forms of MS. In clinical trials, ocrelizumab was shown to be superior to interferon beta-1a, also known as Pfizer/EMD Serono’s Rebif, a widely used treatment for relapsing forms of the disease. Ocrelizumab is designed to selectively target CD20-positive B cells that are thought to contribute to myelin and axonal damage. Ocrelizimab works by binding to CD20 cell-surface proteins on B cells, blocking their action. According to Roche, "Overall safety of Ocrevus in the Phase III studies was similar to interferon beta-1a in the RMS studies and to placebo in the PPMS study."
Source: Roche
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
VERAXA and Voyager to Create Combined Business for Advancing Pipeline of Next-Gen Cancer Therapies
April 23rd 2025The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.
