- Novartis said Friday its leukemia drug Arzerra beat Sanofi's Aubagio in two studies of patients with the most common form of multiple sclerosis, potentially giving the Swiss company a shot at its fifth drug for the disorder.
- The company held back full data for an upcoming European MS meeting. Aubagio is recognized as one of the least effective MS drugs in terms of preventing relapses, so physicians will be eager to see full results before deciding where Arzerra fits in the treatment landscape.
- Arzerra has a similar mechanism of action as Roche's Ocrevus, and could offer self-administration and less patient monitoring as advantages over its Swiss rival if approved.
Roche disrupted the MS market when it launched Ocrevus (ocrelizumab), which quickly became a blockbuster and outsold oral drugs like Novartis' Gilenya despite a need for intravenous infusions.
Novartis' counterpunch is with Arzerra (ofatumumab), a leukemia drug that doesn't figure much in the company's oncology landscape but could have a second life as an MS drug.
Both agents target a protein called CD20, which is present on immunological B cells. The difference is that Novartis, for the MS indication, has prepared a low-dose subcutaneous formulation, while patients taking Ocrevus must receive intravenous infusions.
In its announcement, Novartis was keen to play up Arzerra's self-administration and less intensive patient monitoring, without saying the name of the rival drug directly. On Ocrevus' side, of course, is that it's given only once every six months, compared to monthly shots for Arzerra.
The two trials, called ASCLEPIOS I and II, showed that Arzerra was superior to Aubagio (teriflunomide) on annualized relapse rate in patients with the relapsing form of MS. Novartis will present more data at the ECTRIMS meeting Sept. 11-13.
Aubagio is one of least effective MS drugs, resulting in 15.21 relapses over a lifetime, according to a report on MS drugs prepared by the Institute for Clinical and Economic Review. The only one that performed worse was Biogen's Avonex (interferon beta-1a), which resulted in 15.94.
Thus full detail on the ACELPIOS trials will be necessary before physicians and investors can size up how Arzerra might fit in with other marketed agents.
Payers will also be interested. In that ICER report, the only drug that met typical cost-effectiveness thresholds was Sanofi's Lemtrada (alemtuzumab). Since then the review group has assessed that Novartis' newest MS drug, Mayzent (siponimod) exceeds cost-effectiveness limits in a different population, secondary progressive MS patients.