Emerging trans-Atlantic pharmaceutical company, Atlantic Healthcare, has initiated FDA rolling submission of its New Drug Application for alicaforsen in the treatment of pouchitis.
Pouchitis is a rare and serious form of inflammatory bowel disease for which there are limited treatment options.
Alicaforsen enema has been granted Orphan Drug designation by the FDA and European Medicines Agency, 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.
Toby Wilson Waterworth, CEO at Atlantic Healthcare, said: “The filing of the nonclinical data package initiates the regulatory process for obtaining marketing approval for alicaforsen in the treatment of pouchitis.This is a significant milestone in our corporate development.
“As an antisense therapy, alicaforsen enema has the potential to be first to market in a new class of drugs for the treatment of IBD. Alicaforsen also has the potential to treat multiple inflammatory diseases of the GI tract and elsewhere.
“Atlantic Healthcare is currently exploring additional formulations to extend the use of alicaforsen into other IBD indications.”
Janette Thomas, Director of International Operations at Atlantic Healthcare, said: “Earlier this year we reached agreement with the FDA on our request for a rolling submission for approval of alicaforsen in the treatment of pouchitis.
“This takes Atlantic Healthcare another step closer to bringing alicaforsen to market for patients with pouchitis, a debilitating disease where there remain unmet medical needs and no approved treatments.”
The rolling submission follows previously granted FDA Fast-Track designation for alicaforsen in the treatment of pouchitis.
Fast-Track designation is designed to facilitate the development, and when appropriate expedite the review, of medicines that are intended to treat serious conditions and address unmet medical needs.