Novartis builds case for MS drug ofatumumab as FDA decision looms

Novartis has reported new data with its multiple sclerosis (MS) drug ofatumumab showing that it can suppress disease activity for up to two years, as it waits for an FDA decision on the drug next month.

New results from the Swiss drugmaker’s clinical trials programme for ofatumumab (OMB157) showed that 47% of patients with relapsing MS had no evidence of disease activity (NEDA) in the first year after treatment, rising to almost 88% in the second year.

Ofatumumab – a CD20-targeting antibody – is already used as an intravenous treatment for chronic lymphocytic leukaemia (CLL) under the Arzerra brand name, but has seen its use in that indication pegged back by increased competition.

Novartis reckons the subcutaneous version of the drug can make sales of $1 billion-plus per year as an MS therapy, and challenge other new therapies like Roche’s fast-growing Ocrevus (ocrelizumab), which also targets CD20 and brought in CHF 3.7 billion last year ($3.8 billion) in only its second full year on the market.

If approved it would become the first B-cell-targeting therapy for relapsing forms of MS that can be self-administered by patients at home once a month. A verdict is also due from the European Medicines Agency (EMA) in the first half of next year.

Earlier results from a pair of phase 3 trials – ASCLEPIOS 1 and 2 – showed that the antibody was more effective at cutting relapses than Sanofi’s once-daily oral MS drug Aubagio (teriflunomide), reducing the rate by 50.5% and 58.5% respectively in the two studies.

The new data were presented at the virtual European Academy of Neurology (EAN) congress, and showed that Aubagio was also less effective at banishing disease activity. In the first year 34.5% of patients on Sanofi’s drug achieved NEDA, rising to 48.2% in year two.  

“Achieving no evidence of disease activity is widely recognised as an important treatment goal for MS therapies,” said ASCLEPIOS clinical investigator Prof Ludwig Kappos of University Hospital Basel.

If approved ofatumumab won’t have the same breadth of approved indications as Ocrevus, as Roche’s drug can be used in both relapsing and primary progressive forms of MS.

There’s also a big difference between the two drugs when it comes to their dosing. Patients will have to decide whether they prefer to self-inject ofatumumab once a month, or visit a clinic for an intravenous infusion of Ocrevus every six months.

The coronavirus pandemic could be a lift for Novartis on the dosing issue, given the reduced access to healthcare services, although lockdowns are now starting to be lifted.

Novartis Pharma president Marie-France Tschudin said last month that “now more than ever, bringing a B-cell therapy that’s highly efficacious and administered at home is highly attractive.”

“Our goal is that when patients come back, we’ll make it easy for them to start on ofatumumab,” she added.

Novartis acquired the drug from GlaxoSmithKline and Genmab in 2015 in a $1 billion deal.

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