Actelion receices FDA approval of Uptravi for the treatment of pulmonary arterial hypertension

Vallerie McLaughlin MD, Director of the Pulmonary Hypertension Program in the Division of Cardiovascular Medicine at the University of Michigan, United States, commented: "The prostacyclin pathway has long been recognized as a key target in PAH treatment. However, until now, it has been underutilized. This is in part due to the significant burden existing prostanoid treatments have placed on the patients and on those supporting them. The approval of Uptravi with its convincing long-term outcome results means that many more patients can benefit from this pathway and be treated much earlier in the course of their disease."

Jean-Paul Clozel, MD and CEO of Actelion, commented: "Today's FDA approval of Uptravi is another major landmark for Actelion. Together with our partners at Nippon Shinyaku we are proud to be able to offer an outstanding oral therapy targeting the prostacyclin pathway. The label for Uptravi recognizes the improvement in long-term outcomes, including reducing the risk of hospitalization for PAH regardless of whether patients received background therapy including an ERA, a PDE-5 inhibitor, or - for the first time ever in PAH - on top of a combination of both, an ERA and a PDE-5 inhibitor."

Jean-Paul Clozel concluded: "Uptravi will significantly expand the options to delay disease progression after initiation of therapy with a baseline treatment like Opsumit and well ahead of Veletri for the late disease stage. Actelion now has an unparalleled portfolio of treatments across the continuum of care in PAH that offer a combination of long term-efficacy, safety and convenience."