Mithra Reports Positive Review From DSMB On European Phase 3 Program For DONESTA

(RTTNews) - Mithra has received a positive review from the independent Data and Safety Monitoring Board, or DSMB on its phase 3 program for DONESTA, an investigational, next generation hormone therapy medicine containing estetrol for the treatment of the symptoms of menopause. The DSMB recommended continuing the phase 3 trial in Europe following regular safety assessment.

Graham Dixon, Chief Scientific Officer of Mithra, said, "This DSMB recommendation allows us to continue the extension of the DONESTA phase 3 trial in Europe, which will generate important data for our marketing authorization applications."

Mithra plans to submit DONESTA for the treatment on menopause symptoms for approval by regulators in the U.S. and Europe in fourth quarter, 2024.

Mithra Pharmaceuticals SA is a Belgian biopharmaceutical company. ESTELLE and DONESTA are registered trademarks of Mithra Pharmaceuticals or its affiliates.

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