Novartis’ MS therapy Kesimpta wins NICE backing

Novartis’ Kesimpta has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of relapsing remitting multiple sclerosis (RRMS) in adult patients.

Kesimpta (ofatumumab) is the first self-administered, targeted B-cell therapy licensed for adults with relapsing forms of MS with active disease, according to Novartis.

In its final appraisal document, NICE recommended Kesimpta for the treatment of adult patients with RRMS with active disease, defined by clinical or imaging features.

NICE concluded that Kesimpta is a cost-effective treatment that can be used as a first-line therapy or following the use of other treatments for people with RRMS.

The decision is based on results from the two Phase III ASCLEPIOS studies which both met clinical and magnetic resonance imaging (MRI) endpoints.

In these studies, Kesimpta demonstrated a significant reduction in the number of relapses versus Sanofi’s Aubagio (teriflunomide), evaluated as the annualised relapse rate.

Across both studies, 946 patients were assigned to receive Kesimpta and 936 teriflunomide; Kesimpta showed a significant reduction in ARR by 50.5% and 58.5% compared with teriflunomide in ASCLEPIOS I and II, respectively.

“It’s great news that ofatumumab has been approved by NICE for use on the NHS. This means people living with the relapsing form of multiple sclerosis (MS) in England will have access to an effective new disease modifying treatment they can take at home, rather than in a hospital,” said Fredi Cavander-Attwood, policy manager at the MS Society.

“More than 130,000 people live with MS in the UK, and understandably many prefer the convenience of being able to self-administer treatment at home. It can make a big difference to quality of life, as self-injecting removes the need to take regular time off work and travel for appointments,” she added.

Earlier this month, Novartis bagged a green light from both the European Union and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market Kesimpta.