Orion’s collaboration partner Bayer submits application to U.S. FDA for third indication of darolutamide which has become the first ever Orion-originated blockbuster
ORION CORP NEW UNSP/ADR (ORINY)
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Source: GlobeNewswire
ORION CORPORATION INVESTOR NEWS 26 SEPTEMBER 2024 at 11.00 EEST Orion’s collaboration partner Bayer submits application to U.S. FDA for third indication of darolutamide which has become the first ever Orion-originated blockbuster Orion’s collaboration partner Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral androgen receptor inhibitor (ARi) darolutamide. Bayer is seeking approval for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The submission is based on positive results from the pivotal Phase III ARANOTE trial which showed that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mHSPC. The compound is already approved in mHSPC, under the brand name
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