EC approves Roche's Enspryng in NMOSD

The European Commission (EC) has approved Enspryng (satralizumab), from Swiss pharma giant Roche (ROG: SIX), 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).

Developed by Japanese drug major Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Roche, Enspryng is the first and only NMOSD 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 the approval of Enspryng, we now have a treatment option with a favorable 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, people with NMOSD now have the flexibility to administer treatment at home, which may alleviate the need to travel for hospital appointments,” he added.

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 seropositive NMOSD. AQP4-IgG are present in around 70%-80% of people with NMOSD, who tend to experience a more severe disease course compared to those not expressing AQP4-IgG antibodies.