The recent first global approval of ocrelixumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In late March 2017, ocrelizumab (Ocrevus™), developed by Genentech, received its first global approval in the US for the treatment of multiple sclerosis (MS) in adult patients with relapsing (RMS) or primary progressive (PPMS) disease.[1] Ocrelizumab is an intravenously infused humanised anti-CD20 monoclonal antibody. The precise mechanism of action against MS is yet unknown, but it is believed to involve the selective depletion of CD20-expressing B cells via complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and induction of apoptosis

Multiple sclerosis has an estimated US prevalence of 400,000 people, and is said to be growing at a rate of 200 newly diagnosed patients per week. Overall approximately 2.5 million people are affected globally.[2]

Ocrelizumab is a first-in-class agent that targets B cells instead of T cells as is common with other marketed agents for MS.[3] Despite the need for long-term therapy for this disease, the fact that ocrelizumab is prescribed as a single infusion every 6 months will be appealing to patients.

Sandra Horning M.D., Chief Medical Officer and Head of Global Product Development for Genentech described the approval of ocrelizumab as “the beginning of a new era for the MS community… We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS…”[4]

Billy Dunn, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research, echoed these sentiments when he stated that “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.”[1]

Ocrelizumab is awaiting approval in the EU for the same indications. Development of the agent for the treatment of rheumatoid arthritis, systemic lupus erythematosus and lupus nephritis has been discontinued.

For further information related to the first approval of ocrelizumab please visit Drugs. To learn more about the overall development of ocrelizumab across all indications visit AdisInsight.

Image credit:  jdwfoto / Getty Images / iStock 

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