FDA Grants Arena Pharmaceuticals’ PAH Investigational Drug Orphan Drug Status

Author: Leonor Mateus Ferreira
Date Published: September-2014
Source: Pulmonary Hypertension News

The U.S. Food and Drug Administration has granted APD811, an investigational drug candidate internally developed by Arena Pharmaceuticals, orphan drug status. APD811 is an oral agonist of the prostacyclin (IP) receptor, which is designed for the treatment of vasospastic diseases, such as pulmonary arterial hypertension (PAH). “The FDA Office of Orphan Products Development (OOPD) evaluates scientific and clinical data submissions from sponsors to identify and designate drug candidates that could potentially treat rare diseases to help advance the evaluation and development of such products,” explained Craig M. Audet, Ph.D., Arena’s senior vice president of operations and head of global regulatory affairs.