United Therapeutics has announced that the Phase 3 INCREASE study of Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) met its primary endpoint, demonstrating statistically significant improvement in six-minute walk distance (6MWD). All secondary endpoints for the study were also met.
The company said that it plans to submit the results to the FDA in support of an sNDA by mid-2020. Tyvaso was originally approved by the FDA in 2009, and the most recent sNDA approved was in 2017 when the agency okayed use of an updated nebulizer for delivery of the inhalation solution.
The INCREASE study enrolled 326 patients who received either Tyvaso or placebo over a 16-week period. After 16 weeks of treatment, the change in 6MWD was 21 meters greater for patients who got Tyvaso compared to placebo. According to United Therapeutics, “the safety profile was consistent with previous Tyvaso studies in PAH and known prostacyclin-related adverse events.”
United Therapeutics Chairman and CEO Martine Rothblatt said, “I am pleased to announce the successful outcome of the INCREASE Phase 3 trial of Tyvaso in a unique kind of pulmonary hypertension, a variant that has no approved therapy. Some 30,000 Americans suffer from this disease, called WHO group 3 pulmonary hypertension. It is a tremendous testament to our head of product development, Dr. Leigh Peterson, that her team used the unique characteristics of our inhaled medicine to achieve a highly statistically significant proof of efficacy while seeming to avoid the safety issues that have plagued systemic therapeutics.”
Read the United Therapeutics press release.
