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.”
