An expert’s take on the biologic’s points of distinction
The FDA’s March 28 approval of ocrelizumab (Ocrevus™) marked the first time a therapy has been cleared by the agency for treatment of primary progressive multiple sclerosis (MS). The humanized monoclonal antibody given by IV infusion was also approved for treatment of relapsing forms of MS.
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Amid the buzz surrounding this milestone approval, straightforward expert perspective on what distinguishes ocrelizumab is welcome. That’s precisely what Robert Bermel, MD, of Cleveland Clinic’s Mellen Center for Multiple Sclerosis and Research delivers in this five-minute video reviewing the agent’s mechanism of action, what makes it unique among MS therapies to date, and exactly what it achieved in pivotal trials for both relapsing and primary progressive MS. (A longer version of the video for patient education purposes is available here.)
Ocrevus is a medication that we would consider a second-generation type of medication. It grew out of the use of an initial medication called rituximab or Rituxan®. There was an initial small trial… showing success in relapsing, remitting MS, and out of that grew the theory that B cells were actually quite important to the MS disease process… Ocrevus was studied in three trials total that were pivotal trials that led to its FDA approval to large-scaled trials in relapsing, remitting MS, and all three trials showed the medication to be effective, safe and generally really well tolerated…
It’s a humanized monoclonal antibody… that binds to a unique protein on the surface of… B cells… What happens is when the drug binds to the cells it depletes or causes the death of those B cells, and B-cell depletion happens rapidly, and it lasts for six to 12 months after a dose of the medication.
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