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Approval based on data from the randomized,
double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional
Ocrevus dosing regimen
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Shorter infusion time will further improve
the twice-yearly treatment experience for Ocrevus, the only B-cell therapy for
relapsing and primary progressive MS with a twice-yearly dosing schedule
South San Francisco, CA — December 14, 2020 —
Genentech,
a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that
the U.S. 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 progressive multiple sclerosis (MS) who have
not experienced any prior serious infusion reactions (IRs). The approval was
based on data from the randomized, double-blind ENSEMBLE PLUS study.
“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 U.S.,” said Levi Garraway, M.D., Ph.D., chief
medical officer and head of Global Product Development. “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 showed similar frequency and severity of IRs for a two-hour
Ocrevus infusion time vs. the previously approved 3.5-hour time in patients
with relapsing-remitting MS (RRMS). The first dose was administered per the
approved dosing schedule (two 300 mg intravenous [IV] infusions separated by
two weeks) and the second or later doses (600 mg IV infusion) were administered
over a shorter, two-hour time.
Read the complete press release here
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