Orion and Bayer Submit Marketing Authorization Application to EMA for Darolutamide

Orion Corporation and Bayer have announced, in a Mar. 8, 2019 press statement, that they have submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

The submission is based on positive data from the Phase III ARAMIS trial, which included men with nmCRPC and demonstrated the treatment plus androgen deprivation therapy (ADT) resulted in a statistically significant improvement in metastasis-free survival (MFS).

Bayer has recently completed the rolling submission of a new drug application to the United States Food and Drug Administration and has also submitted an application to the Ministry of Health, Labor and Welfare (MHLW) in Japan. Additionally, the company is discussing submission with other health authorities.

“Darolutamide is highly effective in the patient population with nmCRPC, and it has a side-effect profile that parallels that of placebo,” said Christer Nordstedt, MD, PhD, senior vice-president, Research and Development, Orion Corporation. “Patients who received darolutamide had substantially longer MFS in the ARAMIS trial, and there was also a strong trend for improved overall survival. These results are truly exciting. We are looking forward to taking the next steps in bringing darolutamide to men with nmCRPC and their treating physicians.” 

Source: Orion Corporation