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Excitement to Cautious Optimism — Reactions to Approval of Ocrevus
By Magdalena Kegel March 29, 2017
The historic approval of Ocrevus (ocrelizumab), the first-ever treatment for primary progressive multiple sclerosis (MS), set off ripples in the relatively calm waters of MS news reporting. The drug, which was also approved Tuesday as an unusually effective and safe treatment for relapsing MS, is viewed as a game-changer by many experts in the field.
“The FDA’s approval of Ocrevus is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B-cell targeted therapy,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a press release.
“We believe Ocrevus, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine,” she added.
Genentech’s approval statement did not hold any surprises, with Ocrevus being approved for both relapsing and primary progressive forms of MS, as studied in three Phase 3 clinical trials.
“Multiple sclerosis can have a profound impact on a person’s life,” Billy Dunn, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA’s official release. “This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”
The drug, with an annual list price of $65,000 a year (about 25 percent less than Rebif, the active control in the RMS trials), will be available to patients in the U.S. within two weeks.
Brigham and Women’s Hospital
The Partners Multiple Sclerosis Center, located at the Brigham and Women’s Hospital, Harvard Medical School, is a leading institution in the area of multiple sclerosis, providing comprehensive patient care, innovative technology, and ongoing clinical research trials. The clinical facilities at the MS Center are designed specifically with the MS patient in mind. The MS Center has specialized exam rooms, an on-site infusion facility, and a highly experienced personnel, including specially trained physicians, nurses and an on-site psychologist and social worker. A dedicated MRI scanner and an image-processing laboratory solely for MS patients, provide advanced imaging and quantitation of the MS process. The Partners MS Center is equipped to proved the best level of care for MS patients and is committed to continuous clinical and laboratory research, in an effort to discover a cure for multiple sclerosis. Now located within the new state-of-the-art Building For Transformative Medicine at BWH this renowned group will be working side-by-side with a collaboration of the brightest and best professionals within the realm of neurologic disease. Learn more.