CHMP clears way for EU approval of Novartis' MS drug

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

Kesimpta (ofatumumab) started life as an oncology drug and was first developed by Genmab and licensed to GlaxoSmithKline who marketed under the brand name Arzerra to treat chronic lymphocytic leukaemia.

But Novartis took control of ofatumumab in 2015 as part of a multi-billion-dollar asset swap with GSK and the big Swiss pharma has reworked the drug as a treatment for relapsing multiple sclerosis.

The drug works by targeting the B-cells that play a role in the development of both diseases and Novartis found that in MS, Kesimpta was more effective than Sanofi’s Aubagio (teriflunomide) and with a similar safety and tolerability profile in untreated patients.

The CHMP positive opinion is based on two phase 3 ASCLEPIOS studies that met their primary endpoints when Kesimpta showed a reduction of the annual relapses by over 50% versus teriflunomide and achieved more than 30% relative risk reduction of 3-month confirmed disability progression (CDP).

In a post hoc analysis, nearly nine out of 10 patients treated with Kesimpta achieved no evidence of disease activity in their second year of treatment.

If approved by the European Commission in the coming weeks, Kesimpta will offer patients with relapsing disease a treatment option that can be self-administered every month through an auto-injector pen.

The FDA approved Kesimpta in August last year in a market that is already crowded, with drugs such as Biogen’s oral drug Tecfidera (dimethyl fumarate) and Roche’s Ocrevus (ocrelizumab), which is given by intravenous infusion every six months.

Dr Wallace Brownlee, consultant neurologist and clinical lead for the Multiple Sclerosis Service at the National Hospital for Neurology and Neurosurgery in London, said: “With relapsing forms of MS impacting the highest number of people living with MS in the UK, there is a need for a new treatment option that offers people with MS more flexibility and control in managing their disease outside of traditional hospital settings."

In a separate decision, the CHMP has adopted a positive opinion for Novo Nordisk’s Sogroya (somapacitan), a weekly treatment for adult growth hormone deficiency.

This recommendation is based on the results from REAL 1, a clinical trial programme investigating the efficacy and safety of Sogroya in adults with growth hormone deficiency.

Decisions from the CHMP meeting at the end of last week will be passed on to the European Commission, which is likely to grant marketing authorisations in the coming week.