The European Medicines Agency’s Committee for Medicinal Products for Human US (CHMP) recommended eight medicines for approval at its April 2021 meeting, five of which were novel drugs.
A final decision regarding the approvals is announced by the European Commission, which usually takes two to three months.
The Committee gave a positive opinion for Swiss pharma giant Roche’s (ROG: SIX) Enspryng (satralizumab) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive. AQP4-IgG are present in around 70%-80% of people with NMOSD, who tend to experience a more severe disease course.
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