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Novartis achieves primary endpoints ofatumumab trials
16 September 2019 -

It has been reported today that Switzerland-based Novartis has achieved the primary endpoints in two phase III trials of ofatumumab (OMB157) for treating relapsing multiple sclerosis.

The data from the company's ASCLEPIOS I and II studies indicated that the product was superior to Aubagio (teriflunomide) in patients with relapsing forms of relapsing multiple sclerosis. Both trials were twin, identical design, flexible duration (up to 30 months), double-blind, randomised and multi-centre phase III studies evaluating the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections against Aubagio 14mg oral tablets in adults with relapsing multiple sclerosis.

The product showed a meaningful decrease in multiple confirmed relapses.

The firm hired 1,882 patients with multiple sclerosis aged between 18 and 55 in the studies, which were conducted across 350 sites in 37 countries.

The product is a fully human anti-CD20 monoclonal antibody self-administered by a once-monthly subcutaneous injection that is under development for multiple sclerosis.

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