Enspryng recommended for approval in European Union
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Enspryng to be approved to treat neuromyelitis optica spectrum disorder in people aged 12 years and older, according to a Roche press release.
The recommendation for Enspryng (satralizumab) is for the treatment of patients with anti-aquaporin-4 antibody neuromyelitis optica spectrum disorder (NMOSD) as a monotherapy or in concert with immunosuppressive therapy, the release said.
The treatment, a humanized monoclonal antibody that targets interleukin-6 receptor activity, is administered subcutaneously every 4 weeks after an initial loading dose.
“Enspryng has been shown to reduce the risk of relapse significantly, while also offering a favorable safety profile,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the release. “Additionally, if approved, Enspryng would be the first and only treatment that can be self-administered subcutaneously at home following appropriate training.”
The recommendation is based on phase 3 study results in which Enspryng demonstrated “robust and sustained efficacy results in reducing the risk of relapse and a favorable safety profile in people with AQP4-IgG seropositive NMOSD.”
Roche expects a final decision from the European Commission “in the near future.” The FDA approved Enspryng in August 2020.