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Novartis builds its case for novel MS treatment ofatumumab

Detailed results from phase 3 studies published in NEJM


Novartis has announced that the detailed results from its phase 3 studies of its investigational multiple sclerosis treatment ofatumumab have been published in The New England Journal of Medicine.

The ASCLEPIOS I and II trials evaluated a subcutaneous injection of ofatumumab compared to Sanofi’s once-daily oral Aubagio (teriflunomide) pill in adults with relapsing multiple sclerosis (RMS).

Ofatumumab outperformed Aubagio on both annualised relapse rate (ARR) reduction and relative risk reduction. This included a 51% and 58% reduction in ARR compared with Sanofi’s med, in each study respectively.

Novartis’ drug demonstrated a relative risk reduction of 34% in three-month confirmed disability worsening (CDW), and 32% in six-month CDW. It also showed a significant reduction of gadolinium enhancing (Gd+) T1 lesions (97% and 94% respectively) and a 92% and 85% relative reduction in new or enlarging T2 lesions.

“ASCLEPIOS I and II demonstrate the efficacy and safety of ofatumumab and its potential to become a first-choice treatment option that offers RMS patients the flexibility as they continue to live their lives,” said Krishnan Ramanathan, neuroscience global programme head at Novartis.

Ofatumumab is currently under review with the US Food and Drug Administration (FDA) for the treatment of relapsing forms of multiple sclerosis in adults. It is a fully human anti-CD20 monoclonal antibody (mAb), with a mechanism of action that is designed to deliver B-cells precisely to the lymph nodes, where they are often depleted in MS.

The drug is an important product in Novartis’ growing MS franchise, which currently includes Mayzent (siponimod), a next-generation treatment approved for use in active secondary progressive multiple sclerosis (SPMS).

This approval was particularly important given that it was the first treatment specifically targeting SPMS in over 15 years – around 80% of relapsing and remitting MS patients will go on to develop this variant of the disease.

The MS market has long been dominated by Roche’s blockbuster drug Ocrevus (ocrelizumab), which is used in both relapsing forms of MS and primary progressive MS, although it is facing biosimilar competition in the US and Europe.

That competition paves the way for new entries, including Novartis’ ofatumumab and Bristol-Myers Squibb’s oral sphingosine 1-phosphate (S1P) receptor modulator ozanimod which is also currently under review with the FDA as a treatment for RMS.

Article by
Lucy Parsons

6th August 2020

From: Research



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