Posted by Michael Wonder on 02 May 2017
Atlantic Healthcare initiates FDA rolling submission of its new drug application for alicaforsen in the treatment of pouchitis
1 May 2017 - Filing of the nonclinical package marks a key milestone in the process towards obtaining marketing approval of alicaforsen for the treatment of pouchitis.
Atlantic Healthcare announces that it has initiated the rolling submission of its new drug application with the U.S. FDA, and filed its non-clinical package for alicaforsen to treat pouchitis.
Pouchitis is a rare and serious form of inflammatory bowel disease (IBD) for which there are limited treatment options. Alicaforsen enema has been granted Orphan Drug designation by the FDA and the EMA, and FDA fast track designation in recognition of the unmet medical need for this disease. Alicaforsen enema is currently being evaluated in a pivotal Phase 3 trial in pouchitis.
