Kiadis Pharma, a clinical stage biopharmaceutical company, has submitted a marketing authorisation application (MAA) to the EMA for its lead product ATIR101 as an adjunctive treatment in haematopoietic stem cell transplantation (HSCT) for malignant disease.
Blood
The filing is based on the company’s existing clinical data and follows positive interactions with the EMA Rapporteur and Co-Rapporteur, which indicated support for the filing using the single dose Phase II trial as the pivotal study. Application has been submitted under the EU’s centralised procedure, which means the EMA can issue a single marketing authorisation covering all EU countries.
“Submission of this MAA to the EMA marks a pivotal point in Kiadis Pharma’s development and brings us a significant step closer towards commercialising our lead product ATIR101 for the treatment of blood cancer, across the EU,” said Arthur Lahr, CEO of Kiadis Pharma. “The data generated thus far for ATIR101 has been very positive and we are optimistic that we will receive a positive outcome from the EMA during the second half of 2018, allowing us to make ATIR101 available to transplantation centres across the EU in 2019. It is a great achievement that Kiadis Pharma has reached this milestone on its own merit, which only a very few biotech companies accomplish, and it is testament to the strength of the unique data and of the Kiadis Pharma organisation.”
Results from the single-dose trial were published in December 2016 at the Annual Meeting of the American Society of Hematology (ASH). The data demonstrated that the therapy significantly improved overall survival compared to a historical matched control. Additionally, relapse and graft-versus-host-disease (GVHD) rates were significantly lower than those reported for alternative approaches for HSCT.