Genmab & Novartis’ ofatumumab tops Sanofi’s Aubagio in relapsing multiple sclerosis
Genmab and Novartis have revealed positive new data from two Phase 3 studies of its monthly subcutaneous formulation of ofatumumab (OMB157), showing that the anti-CD20 monoclonal antibody “delivered sustained efficacy with a favourable safety profile” in the treatment of relapsing forms of multiple sclerosis (RMS).
In the trials, the drug proved its superiority over Sanofi’s Aubagio (teriflunomide) with a “highly significant and clinically meaningful reduction in the number of confirmed relapses”, as measured by the annualised relapse rate.
The therapy also met its key secondary endpoint of delay in the time to confirmed disability progression.
“It is clear that early initiation of highly effective treatment for MS improves long-term outcomes, and there is a high need for potent, safe, and convenient therapy that can be used to treat MS from the start,” explained Professor Stephen L Hauser, Director of the UCSF Weill Institute for Neurosciences. “The results from ASCLEPIOS are wonderful news for patients who would like to take an effective B-cell therapy with low requirement for monitoring, avoiding visits to an infusion centre.”
John Tsai, Head Global Drug Development and Chief Medical Officer at Novartis, added: “Ofatumumab, if approved, could be a highly attractive treatment option for a broad RMS patient population, including early MS. The powerful study results are a reflection of our commitment to reimagine MS treatment at all stages of the disease.”
It was confirmed that the full data will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm in September. Regulatory submissions are planned to commence before the end of the year.
The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …
On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ …