Roche (SWX: RO, ROG) announced today that the European Commission approved its Enspryng subcutaneous NMOSD treatment.
Basel, Switzerland-based Roche developed Enspryng (satralizumab) to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD).
Approval comes for the treatment as a monotherapy or for use in combination with immunosuppressive therapy (IST). Roche said in a news release that Enspryng is the first and only NMOSD treatment administered subcutaneously every four weeks, offering at-home dosing after appropriate training.
Enspryng demonstrated efficacy in reducing the risk of relapse in those with AQP4-IgG seropositive NMOSD over two Phase III studies, Roche added.
“We thank the NMOSD community for their partnership and are delighted that Enspryng will be available to people in the EU who until now had limited, accessible treatment options,” Roche CMO & head of global product development Dr. Levi Garraway said in the release. “Building on our growing scientific understanding of neuroimmunological conditions, we are confident ENSPRYNG can transform how people with NMOSD are treated by fitting into their day-to-day lives.”
