*.- Pharma Mar S.A. submitted the Marketing Authorisation Application in the European Union at the end of 2016 .*.- The regulatory process for oncological products in Switzerland is independent from the European Medicines Agency (EMEA) .
Madrid, October 4th, 2017.
The regulatory process for an oncological drug in Switzerland is independent from that of the European Medicines Agency´s process (EMEA), to which PharmaMar submitted the corresponding application at the end of 2016.
Aplidin® was designated orphan drug status by Swissmedic, the European Commission and also the Food and Drug Administration (FDA). In the European Union, this status is granted for the compounds that are investigated for the treatment of illnesses that affect 5 per 10,000 inhabitants or less. This gives the sponsor a series of incentives, among which are included the possibility of a priority evaluation by Swissmedic, the regulatory authority in Switzerland.
The submission of this application represents a milestone for PharmaMar. "We have obtained positive results with this molecule in the pivotal phase III study and we believe that Aplidin® could be a novel therapeutic alternative for patients with multiple myeloma that live in Switzerland", says Luis Mora, Managing Director at the Oncology Business Unit at PharmaMar.