US FDA accepts darolutamide NDA for priority review

Following a submission for marketing approval to the European Medicines Agency last month, Finnish drugmaker Orion Corp (Nasdaq OMX: ORNAV) and Germany’s Bayer (BAYN: DE) have now had their New Drug Application (NDA) for darolutamide accepted for review and granted Priority Review for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) by the US Food and Drug Administration.

Bayer and Orion think their drug could offer a safety advantage, and has the potential to become a 1 billion-euro ($1.29 billion)-plus product if approved. Orion and Bayer also have an ongoing Phase III clinical trial – called ARASENS – which is evaluating darolutamide in patients with metastatic hormone-sensitive prostate cancer (mHSPC) and is expected to read out in 2022.

Darolutamide is expected to sell $819 million in 2024, according to EvaluatePharma’s sell-side consensus. Now that the Loxo-derived Vitrakvi (larotrectinib) has been launched, darolutamide is Bayer’s biggest pipeline hope. Whether darolutamide can achieve forecast sales numbers will therefore depend on pricing and marketing muscle at least as much as on its safety profile, says Jacob Plieth of Evaluate’s editorial arm Vantage.