Xoanacyl® (AVA1014) has been licensed from Akebia Therapeutics, Inc. in December 2022. Since then, Averoa has revised the clinical package and the regulatory strategy using all clinical studies and recent scientific publications to address the specific needs of the European market. The EMA filling is supported by 3 pivotal clinical studies performed by Keryx Biopharmaceuticals, a wholly owned subsidiary of Akebia Therapeutics Inc.
Co-founder of Advicenne in 2007 and Panntherapi in 2020, he is an expert in the clinical development of innovative products for pharmaceutical and biotech industry. He has conducted many clinical studies and has successfully conducted numerous drug development programs in the field of the central nervous system (CNS) and kidney diseases. In particular, he successfully conducted the proof-of-concept study of the « Blockbuster » duloxetine (Cymbalta, Xeristar, Yentreve), approved by the FDA in 2004. His long history of interactions with the U.S. FDA and European (EMA) regulatory agencies provides Averoa with a strategic regulatory vision that is essential to its development.
