US, EU reviews start for Novartis’ Ocrevus rival ofatumumab

Novartis’ cancer therapy ofatumumab has moved closer to its second life as a treatment for multiple sclerosis, with a regulatory decision in the US due in June and in Europe in the first half of next year.

If approved, ofatumumab could become the first B-cell-targeting therapy for relapsing forms of MS that can be self-administered by patients at home once a month, according to the Swiss drugmaker. It could also mount a challenge to Roche’s fast-growing MS therapy Ocrevus (ocrelizumab).

Novartis already markets the CD20-targeting drug for chronic lymphocytic leukaemia (CLL) as Arzerra, after acquiring the drug from GlaxoSmithKline and Genmab in 2015 for $1 billion. The company has scaled down sales in CLL however, making it available on a compassionate-use basis in the face of strong competition from other drugs including Roche’s Gazyvaro (obinutuzumab).

Ofatumumab’s new lease of life as an MS therapy stems from the two phase 3 trials – ASCLEPIOS 1 and 2 – that showed it was able to reduce the number of relapses experienced in a year by patients with relapsing-remitting forms of MS.

The antibody was shown to be more effective at cutting relapses than Sanofi’s once-daily oral MS drug Aubagio (teriflunomide), by 50.5% and 58.5% respectively in the two studies, and also outperformed the rival drug on delaying the time to confirmed disability progression.

A phase 1 companion study called APLIOS has also been conducted to show that delivery of the drug using an autoinjector pen – an important factor to encourage take-up by MS patients – is as effective as the pre-filled syringe formulation used in Arzerra.

If the reviews are positive, ofatumumab will enter the market at a time when the MS category is being shaken up by new entrants like Ocrevus, which has had a stellar roll-out in both relapsing and progressive forms of MS since its launch in 2017. Sales last year rocketed 57% to $3.8 billion, and GlobalData thinks it could reach $6.8 billion by 2025.

Ofatumumab is a close challenger to Roche’s drug as Ocrevus also works via the CD20 receptor on B-cells, and importantly also extends the treatment options for MS patients.

The top-line impact on relapse rates looks similar between the two drugs, with the usual caveat about interpreting data from different studies.

That said, a big difference between them lies in their route of administration. Patients and their physicians 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.

Novartis also claims that there is less need for patient monitoring with its drug. With Ocrevus, patients need to stay in hospital for at least an hour after the three to four-hour dosing period to be monitored for side effects.

Novartis’ long heritage in MS could also stand in ofatumumab’s favour if it makes it to market in the new indication.

It would slot into Novartis’ portfolio alongside its sphingosine 1-phosphate receptor modulators Gilenya (fingolimod) and Mayzent (siponimod), as well as interferon beta-1a biosimilar Extavia and Glatopa (glatiramer acetate), a generic of Teva’s Copaxone.