News

Finnish pharmaceutical company Orion has announced that its partner Bayer is applying for a third application of its prostate cancer drug, darolutamide, in the US.

Bayer has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for darolutamide, an oral androgen receptor blocker, in combination with standard hormonal treatment androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The application is supported by the results from the phase 3 ARANOTE trial.

Liisa Hurme, CEO of Orion, commented: “This is a historic achievement for Orion and yet another proof of the high quality of our research and development work that has been going on for years. With the current level of performance continuing, the future looks bright for darolutamide. Both our clinical development pipeline and our research pipeline have also strengthened recently. With this development, we are improving the chances that we will be able to meet the diverse needs of patients and bring new innovative medicines to the market in the future.”

Bayer is a biotechnology and pharmaceutical company based in Germany.