EMA clears BMS’ oral multiple sclerosis drug Zeposia

Bristol-Myers Squibb now has a green light for its oral, once-daily multiple sclerosis therapy Zeposia on both sides of the Atlantic, with EMA approval this week following an FDA go-ahead in March.

The EU regulator has cleared Zeposia (ozanimod) for the treatment of adults with relapsing/remitting forms of MS with active disease, and according to BMS is the only drug in the S1P receptor modulator class with this label.

Zeposia is one of the drugs that was highlighted by BMS as the driver of its $74bn takeover of Celgene, and according to EvaluatePharma will become a $1.6bn drug in 2024.

For its part, BMS reckons Zeposia could go much higher, perhaps as high as $5bn at peak, despite entering an increasingly competitive market for MS across both oral and injectable/infused therapies.

There are already two S1P drugs on the market from Novartis – Gilenya (fingolimod) which is heading for patent expiry and newer entrant Mayzent (siponimod) which has a sizeable lead over Zeposia in the market but has been growing slowly – plus others in the pipeline from Johnson & Johnson and Mitsubishi Tanabe.

There are other entrenched oral therapies to contend with, notably Biogen’s Tecfidera (dimethyl glutamate) which also has low-cost generics on the horizon that could exert downward pressure on oral therapies, follow-up Vumerity (diroximel fumarate) and Sanofi’s Aubagio (teriflunomide).

On the injectable/infusion side, Roche’s anti-CD20 antibody Ocrevus (ocrelizumab) is already a big seller with sales of $3.8bn last year, and has just been approved by the EMA in a shorter two-hour infusion given once every six months.

Meanwhile, J&J’s rival anti-CD20 drug ofatumumab – self-administered by subcutaneous injection once a month at home – is heading for an FDA decision next month and an EMA verdict in the first half of this year and has also been tipped for blockbuster sales levels.

Zeposia’s approval is based on data from the SUNBEAM and RADIANCE Part B trials, which showed that the drug was able to cut the annualised relapse rate (ARR) in relapsing/remitting MS patients – as well as the number and size of brain lesions – compared to Biogen’s well-established injectable therapy Avonex (interferon beta-1a).

The importance of the drug to the Celgene deal is clear. It’s one of three products – along with two CAR-T therapies – that need to reach the market by March of next year to generate a $9 contingent value right (CVR) payment from BMS to Celgene investors.

While Zeposia has hit the deadline comfortably, the CVR payout has been jeopardised by regulatory delays for the two cell therapies – liso-cel and ide-cel – at the FDA.