Novartis MS therapy gains MHRA and EC approval

pharmafile | April 8, 2021 | News story | |  European Commission, MHRA, Novartis, pharma, pharma news 

The MHRA and European Commission have both granted marketing authorisation to Novartis for its Kesimpta therapy, for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease.

The decision follows two Phase III trials, which found a significant reduction in MS relapses in patients randomised to receive Kesimpta, with annualised relapse rate falling by 50.5% for those on the treatment. The studies were conducted in 1,882 patients between 18 and 55 years old, across 37 countries.

Kesimpta, otherwise known as ofatumumab, is the first self-administered B-cell therapy for adult patients with RMS with active disease, defined by clinical or imaging features.

Initial decisions on Kesimpta from the National Institute for Health and Care Excellence (NICE), who recommend treatments to the NHS, and the Scottish Medicine Consortium (SMC) are expected later this year.

Approximately 130,000 people currently live with MS in the UK. MS is a chronic disorder of the central nervous system that disrupts the normal functioning of the brain, optic nerves, and spinal cord through inflammation and tissue loss. 

Patients with relapsing forms of MS – including RRMS and SPMS with active disease – experience distinct attacks of symptoms, known as relapses. Around 85% of people are considered to have RRMS at their point of diagnosis.

David Martin, CEO of the Multiple Sclerosis Trust, said: “Ofatumumab can potentially give independence to a group of people who have previously had to rely upon regular medical visits to treat this life-changing condition. We hope ofatumumab will provide people living with relapsing forms of MS a sense of independence, and positively impact their lives by reducing their disease progression.”

Dr Owen Pearson, Consultant Neurologist from Morriston Hospital, Swansea, added: “The MS clinical community welcomes today’s news, which provides us with a new treatment option to support a group of patients who, to date, have continued to experience disease activity with this devastating condition.

“MS is a complex disease, and each individual will respond differently to disease-modifying therapies. The self-administration of ofatumumab benefits both the clinical community and eligible patient community.”

Jack Goddard

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