Posted by Michael Wonder on 08 Feb 2021
Ellodi Pharmaceuticals announces fast track designation granted by the FDA to APT-1011 for the treatment of eosinophilic osophagitis
8 February 2021 - Ellodi Pharmaceuticals today announced that APT-1011 (fluticasone propionate oral disintegrating tablet) has been granted fast track designation by the U.S. FDA for the treatment of eosinophilic oesophagitis, a rare, chronic allergic inflammatory disease characterised by eosinophilic infiltration of the oesophagus.
The fast track designation was granted based on data from the Phase 2b study (FLUTE) evaluating histological remission and symptomatic improvement after 12 weeks of treatment (induction), and the long-term maintenance of these improvements.
