Roche ’s ENSPRYNG approved by European Commission as first and only at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD)

Basel, 28 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved ENSPRYNG ® (satralizumab) for the treatment of adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). ENSPRYNG is the first and only NMO SD treatment that is administered subcutaneously every four weeks, allowing home-dosing after appropriate training.“An NMOSD relapse can be devastating, causing permanent neurological damage and disability that accumulates with subsequent relapses, which is why our goal is to prevent them,” said Prof. Dr. Friedemann Paul, Professor of Clinical Neuroimmunology, Charité Universitätsmedizin Berlin. “With th e approval of ENSPRYNG, we now have a treatment option with a favourable safety profile that significantly reduces relapses in AQP4-IgG seropositive adults and adolescents after their first NMOSD attack or in more advanced disease, either as a monotherapy or in combination with IST. Importantly, peo ple with NMOSD now have the flexibility to administer treatment at home, which may alleviate the need to travel for hospital appointments.”The EC approval is supported by results from two Phase III studies, in which ENSPRYNG showed robust and sustained efficacy in reducing the risk of relapse in people with AQP4-IgG sero...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news

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Basel, 28 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved ENSPRYNG ® (satralizumab) for the treatment of adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). ENSPRYNG is the first and only NMO SD treatment that is administered subcutaneously every four weeks, allowing home-dosing after appropriate training.“An NMOSD relapse can be devastating, causing permanent neurological damage ...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news
Basel, 23 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ENSPRYNG® (satralizumab) as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spe ctrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course.NMOS...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news
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