Biogen Receives Marketing Authorization Recommendation From European Medicines Agency for Zurzuvae

MT Newswires Live07-25

Biogen (BIIB) said Friday the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization in the European Union for Zurzuvae to treat postpartum depression.

Biogen and Sage Therapeutics (SAGE), which discovered Zurzuvae, agreed in 2020 to jointly develop and commercialize Zurzuvae in the US. Under the deal, Biogen has exclusive rights to develop and commercialize Zurzuvae outside of the U.S., excluding Japan, Taiwan, and South Korea.

Biogen said the recommendation for Zurzuvae will now be reviewed by the European Commission for marketing authorization in the European Union. It said it expects a decision to be made in Q3.

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