The MHRA has approved ofatumumab for adult patients with relapsing forms of multiple sclerosis (RMS), manufacturer Novartis has announced.
The self-administered targeted B-cell depleting treatment, which is marketed as Kesimpta, is one of the first drugs to be granted a UK marketing authorisation since the UK’s departure from the European Union.
The licence is based on two Phase III studies in which it demonstrated a “significant reduction” in relapses per year versus teriflunomide tablets among patients with active RMS.
Ofatumumab allows faster repletion of B cells than other anti-CD20 monoclonal antibodies and may “offer flexibility in the management of RMS,” said Novartis.
Patients with active RMS who are prescribed ofatumumab administer the treatment themselves at home once a month after receiving initial guidance from a healthcare professional.
NICE and the Scottish Medicine Consortium are expected to publish their advice on the medicine later this year.
Fredi Cavander-Attwood, policy manager at the MS Society, says: “It’s positive news that ofatumumab – a self-injecting disease modifying treatment (DMT) – has been given a MHRA licence for use in people with active relapsing remitting multiple sclerosis (MS). More than 130,000 people live with MS in the UK, and many still don’t have access to a treatment that works for them.
“MS is relentless, painful and disabling, and people with MS often tell us about the convenience of being able to have a DMT at home instead of in hospital. For working age adults, self-injecting ofatumumab could alleviate the challenge of having to frequently take time out of work to attend appointments.
“We now await the provisional decisions on the approval of ofatumumab by NICE and the SMC for use on the NHS.”
Chinmay Bhatt of Novartis said: “Ofatumumab demonstrates our commitment to reimagining medicine and we will work closely with all UK stakeholders to ensure eligible patients can start benefitting rom this treatment as quickly as possible.”