United Therapeutics CorporationNew data from Phase 3 trials supports FDA filings for ralinepag and inhaled treprostinil, potentially expanding approved treatments.

United Therapeutics is presenting new analyses of ralinepag and inhaled treprostinil at two European medical conferences as it seeks U.S. approval to expand its pulmonary disease treatments. The presentations draw on the Phase 3 ADVANCE OUTCOMES study of ralinepag in pulmonary arterial hypertension and the Phase 3 TETON program for inhaled treprostinil in idiopathic pulmonary fibrosis, and they could support two applications submitted to the FDA in June. An analysis from ADVANCE OUTCOMES found that ralinepag produced clinical improvement in a lower-risk population and reduced clinical worsening in patients with connective tissue disorders, though numerical results were not disclosed. From the TETON program, nebulized treprostinil improved lung function and reduced serious clinical worsening events, with a larger benefit at higher doses. The company will also present interim findings from the ARTISAN study on parenteral treprostinil dosing and preliminary results from the PHINDER screening study, at the European Society of Cardiology Congress in Munich and the European Respiratory Society Congress in Barcelona.
United Therapeutics CorporationNew data from Phase 3 trials supports FDA filings for ralinepag and inhaled treprostinil, potentially expanding approved treatments.