Roche's MS med ocrelizumab hits FDA fast track, eyeing earlier-than-expected launch

MS Cells
(image courtesy of Roche) A Roche illustration depicting multiple sclerosis in nerve cells.

Watch out, multiple sclerosis drugs. The competition from Roche could arrive sooner than expected.

Roche’s Ocrevus (ocrelizumab) won FDA priority review, the Swiss drugmaker said Tuesday, meaning it could hit the U.S. market by year’s end, slightly ahead of previous “early 2017” expectations.

If approved, Ocrevus is expected to be a formidable competitor, given its data in the primary progressive form of the disease. No other MS drug has yet proven to be effective in those hard-to-treat patients. Ocrevus is also up for approval in the more common form, relapsing remitting MS.

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 Leerink Partners analyst Geoffrey Porges is one of several expecting Ocrevus to grab a “significant” piece of the MS pie. Decision Resources analyst have predicted that the Roche drug will eventually become the preferred second-line MS treatment. Peak sales estimates for the drug top $3 billion.

The bad news for the MS market isn’t just that Roche will be jockeying for attention from doctors and patients, however. Analysts expect Ocrevus to put a squeeze on other MS drugs as Roche competes for reimbursement deals.And the MS category is already under pressure from payers.

In noting increased payer pressure in MS, Bernstein analyst Ronny Gal pointed out last year that prices in the field had been growing by at 15% annually till early 2014, when increases slowed dramatically.

The Roche drug isn’t an apples-to-apples competitor with most of the recently approved MS drugs. It’s an every-six-months infusion, rather than the blockbuster pills from Biogen (Tecfidera) and Novartis (Gilenya). Other infused MS drugs include Biogen’s Tysabri and Sanofi’s newly minted Lemtrada.

It’s not apples-to-apples in another sense, as Roche’s global head of product development, Dr. Sandra Horning, said in announcing the regulatory submissions for Ocrevus. The drug “is the first investigational medicine to slow disability progression in people with relapsing and primary progressive forms of MS,” Horning said. Roche believes Ocrevus “has the potential to help people living with either of these two forms of MS.”

The approval applications, filed in the U.S. and in Europe, are based on three late-stage studies, two of which showed that Ocrevus beat the standard therapy Rebif in relapsing MS. Another study in people with primary progressive disease showed Ocrevus topping placebo at staving off disability. On the basis of the latter study, Ocrevus won breakthrough status at the FDA for treating primary progressive MS.

- see the Roche release

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