EU greenlights subcutaneous version of Roche’s Ocrevus to treat multiple sclerosis

2024-06-25

临床3期临床结果上市批准

The European Commission approved the subcutaneous (SC) formulation of Roche’s Ocrevus (ocrelizumab) to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), maintaining the same twice-yearly dosing schedule as the intravenous (IV) version. The company noted Tuesday that the new formulation is intended to be administered by healthcare providers, either in the clinic or in other settings.

“Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility,” making “it easier for more people…to access their treatment, while also saving time for providers,” said Levi Garraway, chief medical officer at Roche.

The approval was backed by findings from the Phase III OCARINA II study, which showed that SC Ocrevus resulted in non-inferior blood levels, alongside a comparable safety and efficacy profile to the IV formulation. Moreover, over 92% of study participants surveyed reported being satisfied or very satisfied with the SC formulation.

The SC version of the anti-CD20 antibody, which uses Halozyme's Enhanze drug delivery technology, is also awaiting a decision by the FDA in September. In a Firstword poll of US neurologists conducted last year, nearly a third of respondents said they would use SC Ocrevus exclusively over the IV version if approved, and half of those surveyed believed the Ocrevus franchise would gain a significant advantage over other anti-CD20 competitors such as Novartis’ Kesimpta (ofatumumab) and TG Therapeutics’ Briumvi (ublituximab).

Ocrevus remains Roche’s top-selling drug, racking up CHF 6.4 billion ($7.1 billion) in global sales last year, with the EU accounting for nearly CHF 1.1 billion ($1.2 billion) of it.

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