Kiadis Pharma pro­vides update on the Marketing Authorization Application process for ATIR101™ in Europe

Amsterdam-Duivendrecht, The Netherlands, September 27, 2017 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive prod­ucts to make bone mar­row trans­plan­ta­tions safer and more effec­tive for patients suf­fer­ing from blood can­cers and inher­it­ed blood dis­or­ders, today announces that the Company has received and reviewed the Day 120 List of Questions (“LoQs”) for its lead prod­uct ATIR101™ from the European Medicines Agency’s (“EMA”) Committee for Advanced Therapies (“CAT”). Following review of the LoQs, Kiadis Pharma expects that it will be able to address all ques­tions with­in the six months response time that has been agreed with EMA.
Kiadis sub­mit­ted the mar­ket­ing autho­riza­tion appli­ca­tion (“MAA”) for ATIR101™ to the EMA in April 2017 and CAT issued the Day 120 LoQs in September 2017. Under the EMA review process, the CAT review of the MAA will resume with Day 121 upon sub­mis­sion of Kiadis Pharma’s response.
Arthur Lahr, CEO of Kiadis Pharma, com­ment­ed: “We expect to ade­quate­ly address EMA’s ques­tions with­in the com­ing six months. Kiadis Pharma is on track to poten­tial­ly obtain (con­di­tion­al) EMA approval for ATIR101™ in the sec­ond half of 2018, which would allow for a European launch in 2019.

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