U.S. FDA approves darolutamide (NCE) with Orion and Fermion supply chain
Orion Corporation informed 31st July 2019 that U.S. FDA has approved darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC). The compound, which is developed jointly by Orion Corporation and Bayer was approved under the FDA Priority Review designation.
Orion Corporation has been responsible for development and manufacturing of drug substance and drug product for darolutamide from the beginning. Fermion Oy, fully owned subsidiary of Orion Corporation, has developed drug substance process from phase I to commercial phase for darolutamide. Development phase for drug substance and drug product was finalized with succesfull process validation during 2018.
Well prepared supply chain is now ready for commercial supply to US.
Arne Grumann, Vice President, Research and Development, Fermion Oy:
“ The development of Darolutamide API is a great example for the seamless co-operation between drug product and drug substance development and manufacturing.
Noticeably, the FDA must have been well convinced by the NDA file, because it granted the marketing approval without any deficiency letter for the drug substance within an exeptional short period of only 3 months.
During development different particle size materials have been provided using Fermion’s milling capacity along the way. Also, unusually large material supply requirements with multiple hundreds of kilos in the later development phase have been met always on schedule, while at the same time the chemical process was continuously improved using our chemists’ and engineers’ know-how and statistical design to be at a very efficient level now.
Thus, we are extremely pleased to have the FDA approval received and do look forward to the supply of Darolutamide using our new state of the art production facility in the commercial phase and improve prostate cancer patients’ quality of life. “