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FDA approves Novartis’ MS drug Kesimpta for treating relapsed forms of the disease

Published on 21/08/20 at 12:01pm

The FDA has authorised Novartis’ Kesimpta (ofatumumab) for treating patients with relapsing forms of multiple sclerosis (MS), it has been revealed. 

The injectable treatment also covers other forms of MS including clinically isolated syndrome and active secondary progressive disease. Kesimpta targets and delivers B-cell therapy and has shown to have superior efficacy and safety profile compared to similar treatments. It can also be self-administered once a month.

The US regulator originally approved the drug in 2009 for the treatment of chronic lymphocytic leukaemia as an intravenous infusion with a high dose that was administered by a healthcare provider. It was then investigated for treating relapsed forms of MS.

The process of investigating its safety and efficacy in this specific form of the disease took 10 years and involved more than 2,300 patients. Its newest approval is based on results from the Phase 3 ASCLEPIOS 1 and 2 studies where Kesimpta demonstrated superiority compared to teriflunomide in terms of three-month confirmed disability progression, as well as efficacy in reducing the annualised relapse rate and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions.

“When treating patients with RMS, Kesimpta is a meaningful treatment option that delivers both high efficacy and safety with the ability for patients to have more freedom in managing their disease,” commented Novartis President Marie-France Tschudin. “The development of Kesimpta is a great example of our commitment, knowledge and understanding of multiple sclerosis, which enabled us to identify a targeted treatment that can significantly improve patient outcomes and experience.”

The drug is expected to be available in early September and set for a European regulatory review next year.

Conor Kavanagh

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