Novartis has received green lights from both the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market its multiple sclerosis (MS) therapy Kesimpta (ofatumumab).
The drug is a fully human anti-CD20 monoclonal antibody (mAb) thought to work by binding to a distinct epitope on the CD20 molecule, inducing potent B-cell lysis and depletion. It enables faster repletion of B cells versus other anti-CD20 monoclonal antibodies and so may offer flexibility in the management of RMS, according to the drugmaker.
As per its licence, Kesimpta can be used to treat adults with relapsing forms of multiple sclerosis (RMS) with active disease, defined by clinical or imaging features.
Novartis says it has the potential to become a recognised treatment option for eligible UK patients that can be self-administered, with initial guidance from an appropriately trained healthcare professional, once monthly at home via the Sensoready autoinjector pen.
Initial decisions on NHS use of Kesimpta from the National Institute for Health and Care Excellence (NICE) and the Scottish Medicine Consortium (SMC) are expected later this year.
The drug’s approval rides on the back of two Phase III ASCLEPIOS studies, which met primary endpoints demonstrating a significant reduction in the number of relapses versus teriflunomide, evaluated as the annualised relapse rate (ARR).
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.
“The MS Trust is delighted that ofatumumab, the first self-administered B-cell therapy for people with relapsing forms of MS with active disease, has been granted both MHRA and EMA licence. Relapsing forms of MS can have a serious and difficult impact on all aspects of people’s lives,” said David Martin, chief executive, Multiple Sclerosis Trust. “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.”
“The MS clinical community welcomes [Kesimpta’s approval], 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,” added consultant neurologist Dr Owen Pearson at Morriston Hospital, Swansea. “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.”