(IN BRIEF) Roche announced the European Commission’s approval of a label extension for Evrysdi® (risdiplam) to include a new 5mg tablet, offering a room-temperature stable alternative to the original oral solution for individuals with spinal muscular atrophy (SMA). The tablet, … Read the full press release
Posted in Healthcare, Pharma & Biotech, Science, Switzerland, Technology
Tagged 5mg tablet, bioequivalence, clinical development, clinical study, disease-modifying treatment, European Commission, Evrysdi, family caregivers, label extension, Nicole Gusset, non-invasive treatment, PTC Therapeutics, risdiplam, Roche, SMA, SMA Europe, SMA Foundation, SMA patients, SMN protein, spinal muscular atrophy, treatment flexibility
New data show pre-symptomatic babies with spinal muscular atrophy (SMA) treated with Evrysdi maintained the ability to swallow Evrysdi has demonstrated consistent clinically meaningful efficacy in adults, children, and babies two months and older and is now approved in 58 countries worldwide Further … Read the full press release
Posted in Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged DMD, Duchenne muscular dystrophy, Endeavor, Evrysdi, gene therapy, Hammersmith Infant Neurological Examination, HINE-2, Levi Garraway, M.D. Ph.D, motor milestones, neuromuscular, RAINBOWFISH study, risdiplam, Roche, Sarepta, SMA, spinal muscular atrophy, SRP-9001, World Muscle Society (WMS) Virtual Congress
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