U.S. FDA accepts New Drug Application for review and grants Priority Review for darolutamide

Orion Corporation                  Press release                        29 April 2019 at 3.00 p.m. EEST

U.S. FDA accepts New Drug Application for review and grants Priority Review for darolutamide

Orion Corporation and Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for review and granted Priority Review for darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) in the U.S.

The NDA and Priority Review status were based on data from the Phase III ARAMIS trial in men with nmCRPC.¹ Darolutamide is an investigational, non-steroidal androgen receptor (AR) antagonist with a distinct chemical structure that binds with high affinity to the receptor, inhibiting the growth of prostate cancer cells.

"Darolutamide is highly effective in the patient population with non-metastatic castration-resistant prostate cancer, and it has few adverse effects with a profile that parallels that of placebo. We are looking forward to taking the next steps in bringing darolutamide to men with nmCRPC and their treating physicians. With the NDA acceptance for review and Priority Review designation, we are an important step closer to bringing darolutamide to patients as quickly as possible", said Christer Nordstedt, MD, PhD, Senior Vice President, Research and Development, Orion Corporation.

The FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

Bayer recently submitted an application to the European Medicines Agency and the Ministry of Health, Labor and Welfare (MHLW) in Japan. Bayer is also in discussions with other health authorities regarding submissions.

Darolutamide is being developed jointly by Orion Corporation and Bayer.

About ARAMIS
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.