Posted by Michael Wonder on 17 Aug 2020
United Therapeutics announces U.S. FDA filing acceptance of supplemental new drug application for Tyvaso for pulmonary hypertension associated with interstitial lung disease
17 August 2020 - United Therapeutics today announced that the U.S. FDA accepted for review the supplemental new drug application for Tyvaso (treprostinil) inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease.
United Therapeutics expects the agency's review to be completed in April 2021.
The application is based on data from the Phase 3 INCREASE clinical study of Tyvaso in adult patients suffering from World Health Organization Group 3 pulmonary hypertension associated with interstitial lung disease.
