On 28th June 2021, the company Roche announced, the European Commission has given the approval for ENSPRYNG for the purpose of treating the adolescents and the adults over 12 years of age, who are living with the anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD). The treatment is going to be a monotherapy, or it will be in the combination with the immunosuppressive therapy (IST).
Roche’s ENSPRYNG has been the first and only treatment for the NMOSD, which is mainly administered subcutaneously in every four weeks, which then allows the home-dosing after the proper training.
Dr. Friedemann Paul, professor of neurology at a charity university in Berlin said, an NMOSD relapse can be more dangerous, and it can possibly cause permanent neurological damage and disability, which is accumulating with the subsequent relapses, that is why their main goal is to prevent the people suffering from NMOSD.
Dr. Friedemann Paul also said, with the help of the approval for ENSPRYNG from the European Commission, they are now having an option for the option of treatment along with the favorable safety profile, which significantly decreases the relapses in adolescents and adults, that are AQP4-IgG seropositive after their first attack of NMOSD, either as a monotherapy or in combination with the IST.
The approval of the European Commission has been supported by the results from the two-Phase III studies, in which the ENSPRYNG have been showing the sustained and robust efficacy in the process of decreasing the risk of the relapse in the people affected with the AQP4-IgG seropositive NMOSD.