Roche's much-anticipated MS game-changer, Ocrevus, nabs its FDA green light

The new med Roche has been anticipating—and the multiple sclerosis market shake-up drugmakers have been dreading—is here.

On Tuesday, regulators approved the Swiss drugmaker’s Ocrevus to treat two forms of the disease—relapsing remitting MS and the harder-to-treat primary progressive form—in adult patients. The thumbs-up follows a three-month delay, when the agency asked Roche for additional data on the Ocrevus manufacturing process.

Now, the wait is over for Roche, which stands to win big with the blockbuster wannabe. It's pricing the med at $65,000 per year, marking a 25% discount to Merck KGaA rival Rebif, a drug it topped in clinical trials, and a 20% discount, on average, to other MS therapies, Mizuho analyst Salim Syed wrote in a note to clients.

All told, EvaluatePharma has pegged Ocrevus as the No. 1 drug approval of 2017, at least in terms of 2022 sales; it’s predicting the newcomer will rack up $4.1 billion that year.

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One reason? Ocrevus is the first product ever to win approval for hard-to-treat primary progressive MS, which affects one in 10 MS sufferers, Roche says. And that’ll help the company "argue convincingly for a high price outside the U.S., resist payers in the U.S., and own the segment, without the competition that fragments" the $19 billion global market for relapsing disease, also known as RRMS, Bernstein analyst Tim Anderson has said.

That’s not to say Roche isn’t planning to make a splash in RRMS. It is—and in more ways than one. For starters, Ocrevus has already shown it can top industry heavyweight Rebif from Merck KGaA at quashing disease activity in that realm. It’s also an every-six-months infusion, meaning it’ll have a convenience edge over other infused meds such as Biogen’s Tysabri.

RELATED: Roche poised for MS coup with success in hard-to-treat progressive form

All things considered, Ocrevus’ arrival will "increase intermediate term formulary pressure" onto the already payer-squeezed RRMS space, Bernstein analyst Ronny Gal and other industry watchers have predicted.

For Roche, though, things are looking up, and approval is coming at an opportune time. Some of Roche’s key cancer giants—which have powered the Basel-based behemoth’s top line for years—are aging, with biosimilars makers lining up to attack.

Editor's note: This story has been updated with pricing information.