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If approved, ENSPRYNG will be the first and only treatment available to both adults and adolescents from 12 years of age with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD in the EU
ENSPRYNG is the only subcutaneous treatment option for NMOSD that can be administered at home every four weeks
Recommendation is based on results from the two pivotal Phase III
SAkuraStar
SAkuraSky studies, in which ENSPRYNG demonstrated robust and sustained efficacy in reducing the risk of relapse and a
favourable safety profile
NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system that can cause blindness, muscle weakness and paralysis
Investegate |F Hoffmann-La Roche Ltd Announcements | F Hoffmann-La Roche Ltd: CHMP recommends EU approval of Roche s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD) investegate.co.uk - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from investegate.co.uk Daily Mail and Mail on Sunday newspapers.
New data for Roche’s OCREVUS (ocrelizumab) reinforce significant benefit on slowing disease progression in relapsing and primary progressive multiple sclerosis F. Hoffmann-La Roche Ltd Basel, SWITZERLAND
85% of treatment-naïve, early-stage relapsing-remitting multiple sclerosis (RRMS) patients achieved no evidence of disease activity (NEDA) in open-label Phase IIIb ENSEMBLE study
OCREVUS significantly slowed loss of brain tissue within T2 MRI lesions in primary progressive multiple sclerosis (PPMS) in post-hoc analysis of Phase III ORATORIO study
OCREVUS-treated patients show highest adherence and persistence rates compared with other disease-modifying therapies (DMTs) in two-year U.S. claims analysis
Basel, 16 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new OCREVUS® (ocrelizumab) analyses supporting its significant benefit on disease progression in early-stage relapsing-remitting multiple sclerosis (RRMS) and primary progressi
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Required fields 85% of treatment-naïve, early-stage relapsing-remitting multiple sclerosis (RRMS) patients achieved no evidence of disease activity (NEDA) in open-label Phase IIIb ENSEMBLE study OCREVUS significantly slowed loss of brain tissue within T2 MRI lesions in primary progressive multiple sclerosis (PPMS) in post-hoc analysis of Phase III ORATORIO study OCREVUS-treated patients show highest adherence and persistence rates compared with other disease-modifying therapies (DMTs) in two-year U.S. claims analysis Basel, 16 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today
announced new OCREVUS(R) (ocrelizumab) analyses supporting its
significant benefit on disease progression in early-stage
relapsing-remitting multiple sclerosis (RRMS) and primary progressive MS
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More than twice as many babies (61% vs. 29%) were able to sit without support for at least five seconds after 24 months compared to 12 months of treatment
Evrysdi increased survival and reduced need for permanent ventilation
Evrysdi has proven efficacy across adults, children and babies 2 months and older
Basel, 15 April 2021 - Roche ((SIX: RO, ROG, OTCQX:RHHBY) today announced new 2-year data from Part 2 of FIREFISH, a Phase 2/3 global study evaluating Evrysdi™ (risdiplam) in infants aged 1-7 months at enrollment with symptomatic Type 1 spinal muscular atrophy (SMA). The data showed Evrysdi continued to improve motor function between months 12 and 24, including the ability to sit without support. The study also showed Evrysdi continued to improve survival, improve ability to feed orally and reduce the need for permanent ventilation . Exploratory data suggested Evrysdi continued to improve the ability to swallow and reduce hospitalisations compared to the natural course