Novartis has announced data supporting a cancer drug it acquired from GlaxoSmithKline and Genmab in a new use in multiple sclerosis, with plans for regulatory filings later this year.
The Swiss pharma already markets ofatumumab under the brand name Arzerra, after acquiring rights in all indications including autoimmune diseases in 2015 for $1 billion from the UK pharma.
Novartis is now repurposing Arzerra as an MS drug, announcing last year that it would only be available in the US to treat chronic lymphocytic leukaemia (CLL) on a compassionate use basis.
The Swiss pharma decided that competition from the likes of Roche’s Gaxyva (onibutuzumab) was too tough in CLL, saying it would only be available in the US on special request from doctors, and has decided to focus on its potential in MS instead.
Novartis bought the drug from GSK as part of a $16 billion asset swap and joint venture deal in 2014, where the Swiss firm received the UK firm’s portfolio of cancer drugs and its vaccines business went the other way.
The 2015 deal with GSK settled the outstanding rights issues to Arzerra, while co-developer Genmab still earns a royalty from net sales.
Ofatumumab works by targeting the CD20 molecule on the surface of B-cells, causing them to die – a mechanism that is useful in leukaemia, when there are too many of these cells, and in MS when they become over-active and begin to attack the patient’s own nervous system.
Novartis said the twin phase 3 ASCLEPIOS I and II studies met their primary endpoints, where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualised relapse rate (ARR).
Important secondary endpoints of delaying time to confirmed disability progression were also met, and top line results will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference beginning on 11th September.
The studies are identical flexible duration (up to 30 months), double-blind, randomised, multi-centre phase 3 studies testing the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections versus daily Aubagio 14mg oral tablets, in adults with a confirmed diagnosis of relapsing MS.
The primary endpoint of both studies was to demonstrate that ofatumumab is superior to Aubagio in reducing the frequency of confirmed relapses as evaluated by the ARR in patients treated up to 30 months.
Secondary endpoints included time to disability progression confirmed at three and six months respectively, confirmed disability improvement at six months, gadolinium enhancing T1 lesions, number of new or enlarging T2 lesions, serum levels of neurofilament light chain (NfL), and rate of brain volume loss.
Safety and the pharmacokinetic properties of ofatumumab were also measured throughout the treatment period.
The market for MS drugs is highly competitive, and Roche has been setting the pace recently with its Ocrevus (ocrelizumab), which has already become a blockbuster following FDA approval in 2017 for relapsing and primary progressive forms of MS.
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