KIADIS SUBMITS RESPONSE TO THE EUROPEAN MEDICINES AGENCY’S DAY 180 SECOND LIST OF OUTSTANDING ISSUES

22.MAY 2019 AT 20:11:16 CET

Amsterdam, The Netherlands, May 22, 2019 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announced that it has sub­mit­ted a response to the European Medicines Agency’s (EMA) sec­ond Day 180 list of out­stand­ing issues for ATIR101. Kiadis sub­mit­ted a mar­ket­ing autho­riza­tion appli­ca­tion (MAA) to the EMA in 2017 seek­ing approval of ATIR101 as an adjunc­tive immunother­a­py for hematopoi­et­ic stem cell trans­plant (HSCT) in adults with late-stage blood can­cer. 
     
The sec­ond Day 180 List of Issues was focused on one remain­ing major obser­va­tion. In draft­ing the company’s response, Kiadis has thor­ough­ly ana­lyzed this obser­va­tion and have cre­at­ed mul­ti­ple analy­ses of exist­ing clin­i­cal data to address this obser­va­tion, includ­ing analy­ses of var­i­ous (pooled) ATIR and his­tor­i­cal con­trol data.

“We received the EMA’s day 180 sec­ond list of out­stand­ing issues in the fourth quar­ter of 2018, and have spent the past few months con­duct­ing addi­tion­al analy­sis of exist­ing data to sup­port our response,” said Arthur Lahr, CEO, of Kiadis Pharma. “With this sub­mis­sion com­plete, we aim to receive an opin­ion from Committee for Medicinal Products for Human Use (CHMP) in 2019. If the CHMP opin­ion is pos­i­tive, it would enable us to receive a con­di­tion­al mar­ket­ing approval from the European Commission, fol­lowed by com­mer­cial use of ATIR101 in a first patient in a European coun­try at the end of 2019.”

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