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Novartis announce robust Phase 3 trials for ofatumumab in MS

Published on 16/09/19 at 11:08am
Novartis HQ

Novartis’ multiple sclerosis candidate has demonstrated strong results in its Phase 3 ASCLEPIOS trials meeting primary endpoints and slashing the risk of progression by 30% compared to Sanofi’s Aubagio.

The drug, a once-monthly injection that patients can administer themselves at home reduced relapse rates by 50.5% and 58.5% in trials compared with Sanofi’s, daily pill Aubagio.

The findings were announced at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Ofatumumab also reduced the risk of patients’ disabilities progressing by a massive 34.4% over three months and 32.4% over six months and additionally was superior in suppressing brain lesions and inflammation than Aubagio.

John Tsai, head of Global Drug Development and Chief Medical Officer at Novartis, said: “Ofatumumab showed high efficacy and a favourable safety profile in people with RMS, offering a potential first B-cell therapy that can be self-administered in the home.”

The ASCLEPIOS I and II trials utilised 1,882 patients with multiple sclerosis between the ages of 18 and 55 years.

Professor Stephen Hauser, Director of the UCSF Weill Institute for Neurosciences added: “It is clear that early initiation of highly effective treatment for MS improves long-term outcomes, and there is great need for potent, safe and convenient therapy that can be used to treat MS from the start.

The results from the ASCLEPIOS are wonderful news for patients who would like to take an extremely effective B-cell therapy with low requirement for monitoring, avoiding visits to an infusion centre.”

The news comes just as Johnson & Johnson’s ponesimod outperformed Sanofi’s Aubagio in Phase 3 trials as well meaning the market for MS could soon be heating up.

Nik Kiran

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