- The U.S. Food and Drug Administration (FDA) has extended its review of an application for approval of ocrelizumab for the treatment of primary progressive and relapsing MS.
- A press release from Genentech, a member of the Roche Group, states that the extension will permit the FDA more time to review additional data submitted regarding the commercial manufacturing process for ocrelizumab. In addition, the company states that the extension is not related to the drug’s safety or efficacy.
- The original FDA approval decision date of December 28, 2016 has been is extended to March 28, 2017.
The U.S. Food and Drug Administration has extended its review of an application to approve ocrelizumab (Ocrevus,™ Genentech, a member of the Roche Group) for use in the treatment of primary progressive MS
and relapsing forms of MS
. Originally, a decision from the agency was expected by December 28, 2016. A decision about the approval is now expected by March 28, 2017.
According to a press release from the company, the extension would permit the FDA more time to review additional data submitted regarding the commercial manufacturing process for ocrelizumab, and is not related to the clinical trial data on benefits and safety. Ocrelizumab is a monoclonal antibody that is classified as a “biologic” therapy. Biologics are generally more complex to manufacture than chemical drugs (such as pills and capsules), as they are made from human and/or animal materials rather than chemical processes.
“The delay is unexpected,” said Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer. “We await the timely resolution of the questions contributing to the FDA’s action, recognizing that people living with primary progressive MS are anxiously awaiting what has the potential to be the first therapy that can impact their disease.”
Ocrelizumab is a monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells, and reduces the numbers of certain B cells that are circulating in the blood. B cells have several functions including making antibodies, and they are believed to play a role in immune-system-mediated damage to brain and spinal cord tissues in MS. Ocrelizumab is administered by intravenous infusion every 6 months.
Results in Primary Progressive MS:
The ORATORIO study involving people with primary progressive MS, which compared ocrelizumab to inactive placebo, met its primary endpoint, showing treatment with ocrelizumab significantly reduced the risk of progression of clinical disability by 24% compared with placebo in 732 people. Compared to placebo, ocrelizumab also reduced the time required to walk 25 feet by 29%, decreased the volume of brain lesions by 3.4%, and reduced the rate of whole brain volume loss by 17.5%, over 120 weeks.
Results in Relapsing MS:
In the OPERA I and OPERA II studies involving people with relapsing MS, which compared ocrelizumab to interferon beta-1a (Rebif,® EMD Serono and Pfizer), ocrelizumab significantly reduced the annualized relapse rate by up to 47% compared with Rebif over two years in a total of 1,656 people with relapsing MS. Ocrelizumab also significantly delayed confirmed progression of disability on the EDSS scale by up to 43% compared with Rebif. Ocrelizumab also significantly reduced active inflammation observed on MRI scans by up to 95%, and total damage on MRI scans by up to 83% compared with Rebif.
The most common adverse events were infusion-related reactions (such as itchy skin, rash, irritation in the throat, flushed face or fever, headache or other symptoms) and infections.
Access to Ocrelizumab:
There are clinical studies taking place which are currently recruiting individuals with MS who meet specific criteria. All participants receive the active therapy, and there is no placebo group.
For general questions about ocrelizumab, contact the Genentech Patient Resource Center at:
Ocrevus is a trademark of Genentech, a member of the Roche Group.
Rebif is a registered trademark of EMD Serono and Pfizer.