Roche Wins FDA Approval For MS Treatment Ocrevus

Switzerland’s Roche Holding AG announced that the US Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for its multiple sclerosis (MS) treatment Ocrevus.

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Specifically, Roche (0QOK) said that the regulatory nod now allows for shorter infusion time, which will further improve the twice-yearly treatment experience of Ocrevus used for relapsing and primary progressive multiple sclerosis (MS).

The drugmaker added that approval was based on data from its randomised, double-blind Ensemble Plus study, which showed consistent safety to the conventional Ocrevus dosing regimen.

Ocrevus is a humanised monoclonal antibody developed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS.

“More than 170,000 people with MS have been treated with OCREVUS – the only approved B-cell therapy with a twice-yearly dosing schedule – and it is the most prescribed MS medicine in the US,” said Roche’s Chief Medical Officer Levi Garraway. “We constantly strive to improve the experience that patients and their physicians have with our medicines, and we believe people with relapsing and primary progressive MS will find the shorter two-hour Ocrevus infusion time to be more convenient.”

The Ensemble Plus study demonstrated similar frequency and severity for a two-hour Ocrevus infusion time compared to the previously approved 3.5-hour time in patients with relapsing-remitting MS (RRMS).

From the Street, Roche scores a cautiously optimistic Moderate Buy Street consensus with 10 recent Buy ratings offset by 3 Hold ratings and 1 Sell rating. Meanwhile, the average analyst price target of SFr.371.72 indicates 22% upside potential from current levels.

Berenberg Bank analyst Luisa Hector recently initiated the stock’s coverage with a Hold rating and a SFr.350 price target. Hector projects solid fundamentals and attractive valuations in the global pharma space.

The analyst forecasts 6% annual sales growth and a 10% earnings compound annual growth rate for the sector through 2024. (See Roche stock analysis on TipRanks).