Posted by Michael Wonder on 26 Dec 2021
Takeda receives complete response letter from the U.S. FDA for TAK-721
21 December 2021 - Takeda today announced that it has received a complete response letter from the U.S. FDA in response to its new drug application for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis, a chronic inflammatory disease of the oesophagus.
The complete response letter indicates the FDA has completed its review of the TAK-721 NDA and determined that it cannot be approved in its present form.
In addition, the FDA recommended an additional clinical trial in order to help resolve FDA feedback.
