CHMP recommends EU approval of Roche ’s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD)

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.NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system, often misdiagnosed as multiple sclerosis, that primarily damages the optic nerve(s) and spinal cord, causing permanent blindness, muscle weakness and paralysis. The disease is characterised by unpredictable relapses and severe disability often occurs following the first NMOSD attack, accumulating with each subsequent relapse. Preventing these relapses is the primary goal for disease management. ENSPRYNG has been recommended for use in people who have only experienced a single NMOSD attack and adolescents, currently unserved NMOSD populations, as well as those with more advanced disease.“Today’s positive CHMP opinion is an important step toward bringing ENSPRYNG to people in the EU living with NMOSD who have limited treatment options,” said Levi Garraway, M.D., Ph.D., Chi...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news