New medicines recommended for approval by EMA's CHMP
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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