Business Wire

Genentech’s Ocrevus Twice-Yearly, 10-Minute Subcutaneous Injection Was Non-Inferior to Intravenous Infusion and Provided Near-Complete Suppression of Brain Lesions

– Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on Ocrevus levels in the blood over 12 weeks – – Ocrevus subcutaneous injection was ...
Nasdaq

FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis

– Approval based on data from the randomized, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional Ocrevus dosing regimen – – Shorter infusion time will further improve the ...
Monthly Prescribing Reference

FDA Approves Shorter Infusion Time for MS Drug Ocrevus

The approval was based on data from the phase 3b ENSEMBLE PLUS study that compared the frequency and severity of infusion-related reactions for a 2-hour Ocrevus infusion time to the previously ...
Business Wire

New Data Further Reinforce Genentech’s Ocrevus (ocrelizumab) as a Highly Effective Treatment for People With Multiple Sclerosis

– 75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to Ocrevus in open-label ...
Seeking Alpha

Genentech Provides Update on Phase III Ocrevus High Dose Study in People With Relapsing Multiple Sclerosis

- MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis - - The ...
Seeking Alpha

TG Therapeutics: Addressing The SC Ocrevus Concern

The launch of Briumvi is off to a solid start, but the stock pulled back recently and fell more after Roche reported positive phase 3 results of subcutaneously administered Ocrevus. The improved ...
Business Insider

Roche: OCREVUS Shorter 2-hour Infusion Time For MS Gets Europe Approval

(RTTNews) - Swiss drug maker Roche (RHHBY) announced Thursday that the European Medicines Agency or EMA has approved a new, shorter two-hour OCREVUS (ocrelizumab) infusion time, dosed twice yearly, ...
Monthly Prescribing Reference

Investigational SC Formulation of Ocrelizumab Noninferior to IV Infusion in MS Trial

Credit: Getty Images. The SC formulation is intended to be administered in 10 minutes twice a year. Positive data were announced from a phase 3 trial evaluating an investigational subcutaneous (SC) ...
STAT

FDA approves Roche’s injectable version of blockbuster multiple sclerosis drug

Jonathan Wosen is STAT’s West Coast biotech & life sciences reporter. You can reach Jonathan on Signal at jwosen.27. Swiss pharma giant Roche won approval from the ...
Pharmabiz

US FDA approves Roche’s Ocrevus shorter 2-hour infusion for relapsing and primary progressive MS

Roche announced that the US Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary ...
STAT

Pioneering the B cell approach in MS

When neurologist Dr. Kathleen Hawker did her medical training in the early 1980s, she was struck by the people she saw with multiple sclerosis (MS), a progressively disabling disease of the central ...