EMA human medicines approvals in 2023
In 2023, the European Medicine Agency (EMA) recommended 77 medicines for marketing authorization. Of these, 39 had a new active substance which had never been authorized in the European Union (EU) before.
Among these are a number of medicines that stand out due to their contribution to address public health needs or the innovation they represent. The Agency recommended two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV).
The EMA also recommended the first advanced therapy medicinal product using a ground-breaking gene-editing technology known as CRISPR/Cas9 to treat two rare blood disorders. This was Vertex Pharmaceuticals’ (Nasdaq: VRTX) Casgevy (exagamglogene autotemcel). The EMA also adopted two positive opinions for medicines for use in countries outside the EU.
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