Atlantic Healthcare wins FDA backing
Atlantic Healthcare plc, which has operations in the Cambridge UK and North Carolina biotechnology clusters, has won a key FDA approval.
The transatlantic pharma company, which has a core focus on gastrointestinal disorders, has received FDA backing to initiate a rolling submission of its New Drug Application for alicaforsen to treat pouchitis – a serious form of inflammatory bowel disease that has limited treatment options.
Toby Wilson Waterworth (pictured), CEO at Atlantic Healthcare, said: “Following a meeting with the FDA in December in which we discussed the preclinical (safety) package for alicaforsen, we are delighted that the FDA accepted our request for a rolling submission of the NDA for alicaforsen in pouchitis.
“We expect to complete the NDA submission following successful completion of our ongoing pivotal Phase 3 trial of alicaforsen in pouchitis.”
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.
It allows more frequent communication with the FDA, the option for rolling submission, and potential eligibility for accelerated approval.