Roche’s multiple sclerosis rival draws near

Plans to commercialise an anti-CD20 drug currently undergoing regulatory approval for treating relapsing forms of multiple sclerosis (MS) are underway, with Neuraxpharma set to enter the Australian market this year.

Briumvi (ublituximab) will face an uphill battle against established competitors such as Roche’s Ocrevus (ocrelizumab), Novartis’ Kesimpta (ofatumumab) and Biogen’s Tysabri (natalizumab) and Merck’s Mavenclad (cladribine).

A key advantage for Briumvi lies in its convenience for patients. The drug offers a one-hour intravenous infusion twice per year following the initial dose, whereas Roche’s Ocrevus requires a two-hour infusion twice a year after the starting dose.

However, Roche’s subcutaneous (SC) injection of Ocrevus presents a competitive challenge. Data from the Phase III OCARINA II trial demonstrates comparable patient outcomes to the IV infusion method. This 10-minute SC injection, administered twice a year, could broaden Ocrevus’ accessibility, making it viable in treatment centres that lack IV infrastructure or have limited IV capacity.

Recent five-year data from the ULTIMATE I & II Phase 3 trials underscore Briumvi’s efficacy in preventing disability progression, with 92% of patients experiencing positive outcomes.

In related news, the first consensus statement for managing MS in Australia and New Zealand has been released.

Senior author Associate Professor Mastura Monif, neurologist and researcher from the Monash University School of Translational Medicine and head of Alfred Health’s Neuroimmunology Service, highlighted the need for updated, locally relevant guidelines.

“New disease-modifying therapies are more effective and better tolerated,” Associate Professor Monif said. “But it’s a much more complex treatment landscape than it was 20 years ago, and there is new evidence being generated all the time on many aspects of the disease. It is really important that the approach used is focused on both the effectiveness and safety for the individual so they can get the best possible outcome.”

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