28.JUNE 2019 AT 18:10:51 CET

Kiadis updates sta­tus of mar­ket­ing autho­riza­tion appli­ca­tion for ATIR101

Amsterdam, The Netherlands, June 28, 2019 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announced that it has received feed­back from the European Medicines Agency (EMA) relat­ed to the mar­ket­ing autho­riza­tion appli­ca­tion (MAA) seek­ing approval of ATIR101 in hematopoi­et­ic stem cell trans­plant (HSCT). As pre­vi­ous­ly announced, Kiadis sub­mit­ted respons­es to the sec­ond Day 180 list of out­stand­ing issues for ATIR101 to EMA in May 2019.  

As part of the review process, EMA today informed Kiadis that it will con­vene a Scientific Advisory Group (SAG) in September, com­pris­ing of experts in hema­tol­ogy and HSCT to assist EMA in arriv­ing at a deter­mi­na­tion. 

“We appre­ci­ate the feed­back from EMA and look for­ward to con­tin­u­ing our inter­ac­tion with them dur­ing the review of our MAA for ATIR101,” said Arthur Lahr, CEO, of Kiadis Pharma. “With the SAG meet­ing now pre­ced­ing the sub­se­quent CAT and CHMP meet­ings as part of the EMA approval process, we are chang­ing our guid­ance to poten­tial EU con­di­tion­al approval in 2020.”

While ini­tial launch in the EU is delayed, Kiadis is on track to com­plete enroll­ment in the Phase 3 ATIR101 HSCT study in 2021 to sup­port poten­tial mar­ket­ing approval in the US. Additionally, the com­pa­ny is  also on track to start the Phase 1/2 stud­ies of CSDT002 in HSCT and relapse and refrac­to­ry acute myeloid leukemia in 2020. With a nov­el cell-based can­cer immunother­a­py plat­form con­sist­ing of both T-cell and NK-cell tech­nolo­gies, Kiadis has the oppor­tu­ni­ty to poten­tial­ly rev­o­lu­tion­ize trans­plants and devel­op nov­el can­cer cell ther­a­pies.

Leave a Reply

Your email address will not be published. Required fields are marked *