Atlantic Healthcare plc files rolling submission at FDA for alicaforsen to treat pouchitis.

Atlantic Healthcare plc ,an emerging trans-Atlantic pharmaceutical company with a core focus on gastrointestinal (GI) disorders, announced that it has initiated the rolling submission of its New Drug Application (NDA) with the FDA, and filed its nonclinical 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 European Medicines Agency (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 III trial in pouchitis.