FDA Grants Orphan Drug Designation to ATXA’s NTP42 for the Treatment of PAH
DUBLIN, IRELAND – March 8, 2018 – ATXA Therapeutics Limited, an early-stage Irish biopharmaceutical company focused on clinical development of novel small molecule drugs to treat Pulmonary Arterial Hypertension (PAH), is pleased to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to ATXA's lead clinical candidate NTP42 for the treatment of PAH. The company received written notification of this rapid decision from the FDA on Wednesday, March 7, 2018. This follows swiftly on from the orphan designation granted by the European Medicines Agency (EMA) last month for the use of NTP42 for the treatment of PAH within the European Union.
"We believe NTP42 could radically transform the treatment of PAH,” said Prof. Therese Kinsella, ATXA Therapeutics' Founder and Chief Scientific Officer. "Receiving both FDA and EMA orphan drug designations validates our scientific rationale and preclinical investigations, and it represents another key step towards achieving our goal of bringing a novel treatment to the patients affected by this debilitating disease.”
Orphan Drug Designation (ODD) is a special status accorded by the FDA to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the US alone. ODD provides drug development companies with up to seven years of drug exclusivity, substantially extending the effective life of a commercial product when it comes to market. It also provides opportunities for annual grant funding, protocol assistance in clinical trial design, tax credits for clinical research costs and other financial benefits such as waivers of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) filing fees.
About ATXA Therapeutics
Headquartered in Dublin, Ireland, ATXA Therapeutics Limited is a spin-out company from University College Dublin whose primary focus is to advance clinical trials and to secure marketing authorization of novel therapies for the treatment of Pulmonary Arterial Hypertension (PAH), serving a previously unmet medical need by offering improved treatment options to the prescribing physician and new hope for the PAH patient. Founded in May 2015, ATXA Therapeutics Limited is the culmination of over 20 years of extensive research and over €15m of grant funding and a proven track record in understanding of the biology and signalling of the human prostanoid receptors in the cardiovascular disease and oncology setting. For more information, please visit www.atxatherapeutics.com.
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