Actelion Submits New Drug for Pulmonary Arterial Hypertension to FDA

Author: Leonor Mateus Ferreira
Date Published: December-2014
Source: Lung Disease News

Actelion has submitted its new treatment for pulmonary arterial hypertension (PAH) to the U.S. Food and Drug Administration (FDA). The company is applying for a New Drug Application (NDA) for selexipag (Uptravi), after having also submitted the drug to the European Medicines Agency (EMA). Actelion is expecting to offer selexipag as a treatment for patients who suffer from PAH, which will make it the first selective oral IP prostacyclin receptor agonist for the disease. The drug, which was originally developed by the Kyoto, Japan-based research company Nippon Shinyaku, has been evaluated in a phase III pivotal study called GRIPHON, whose encouraging results supported Actelion’s recent submission efforts.