Posted by Michael Wonder on 27 Apr 2017
Kiadis Pharma announces filing of marketing authorisation with the European Medicines Agency for ATIR101 in blood cancers
26 April 2017 - Kiadis Pharma today announces it has submitted a marketing authorisation application to the EMA for its lead product, ATIR101.
The Company is seeking marketing approval in the European Union for ATIR101 as an adjunctive treatment in haematopoietic stem cell transplantation for malignant disease.
The filing is based on Kiadis Pharma’s existing clinical data and follows positive interactions with the EMA Rapporteur and Co-Rapporteur which indicated support for the filing using the Company’s single dose Phase II trial with ATIR101™ as the pivotal study. The Company submitted the application under the European Union’s centralised procedure, which permits the agency to issue a single marketing authorisation that is valid across all EU countries.
