Brief: Bayer Applies To U.S. FDA For Third Darolutamide Indication, Orion's First Blockbuster

Orion Oyj

26/09/2024 09:06

Sept 26 (Reuters) - Orion Oyj  ORNBV.HE :
    * COLLABORATION PARTNER BAYER SUBMITS APPLICATION TO U.S.
FDA FOR
THIRD INDICATION OF DAROLUTAMIDE WHICH HAS BECOME FIRST EVER
ORION-ORIGINATED BLOCKBUSTER
    * PHASE III TRIAL SHOWS DAROLUTAMIDE REDUCES RISK OF
PROGRESSION
OR DEATH BY 46%
    * BAYER IS SEEKING APPROVAL FOR USE OF DAROLUTAMIDE IN
COMBINATION
WITH ANDROGEN DEPRIVATION THERAPY (ADT) IN PATIENTS WITH
METASTATIC HORMONE-SENSITIVE PROSTATE CANCER (MHSPC)
    * DAROLUTAMIDE IS DEVELOPED JOINTLY BY ORION AND BAYER
    * DAROLUTAMIDE BECOMES FIRST ORION-ORIGINATED BLOCKBUSTER
WITH
SALES OVER €1 BILLION

Source text for Eikon:  ID:nGNE2zCGnY 
Further company coverage:  ORNBV.HE 

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