Generic name: ocrelizumab
Disease: Multiple sclerosis
2022 sales estimate: $4.1 billion
There’s a reason Ocrevus is expected to tie or lead all other new meds in the 2017 launch department—and that’s because the multiple sclerosis market is headed for a serious shakeup.
The Roche newcomer is the first med to show it can top placebo at staving off disability in patients with primary progressive MS, a hard-to-treat form of the disease that affects 15% of multiple sclerosis patients. That status landed Ocrevus the FDA’s breakthrough designation last February.
But Ocrevus has proven itself a force to be reckoned with in relapsing remitting multiple sclerosis, too. Two late-stage studies supporting the med’s FDA approval application showed that the Swiss pharma giant’s candidate could top standard therapy Rebif from Merck KGaA.
Back to that breakthrough designation for a second, though. While some predicted the tag might win Ocrevus an approval ahead of the new year, that forecast didn't pan out. In late December, Roche announced that the FDA had pushed the drug's PDUFA date to March 28, 2017, from Dec. 28, 2016, citing questions about its production.
Roche’s fellow MS drugmakers certainly didn’t mind the delay. Analysts predict that Ocrevus’ arrival will ramp up payer pressure on the entire MS market, which is already experiencing a pricing cool-down thanks to formulary management.