Bayer applies to U.S. FDA for third use of Orion's blockbuster darolutamide

Orion’s collaborator, Bayer, has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral androgen receptor inhibitor (ARi) darolutamide. This submission aims to gain approval for the use of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC). The application is supported by promising outcomes from the Phase III ARANOTE trial, which indicated that darolutamide combined with ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in mHSPC patients.

Darolutamide is already approved under the brand name Nubeqa® for use in mHSPC patients in conjunction with ADT and docetaxel across more than 80 countries. Additionally, it is sanctioned for use with ADT for managing non-metastatic castration-resistant prostate cancer (nmCRPC) in patients at high risk of developing metastatic disease in over 85 countries. This drug is a joint development effort between Orion and Bayer.

In September 2024, Bayer announced that Nubeqa® achieved in-market sales surpassing one billion euros year-to-date. This milestone establishes darolutamide as the first product originated by Orion to reach blockbuster status.

“This is a landmark achievement for Orion and further evidence of the high-quality research and development that we have been conducting for many years. Given the current success, the future prospects for darolutamide are promising. Moreover, our clinical pipeline as well as our research pipeline have seen recent improvements, increasing the likelihood of commercializing new, innovative medicines in the future to address various unmet patient needs,” commented Liisa Hurme, President and CEO of Orion Corporation.