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United Therapeutics Announces U.S. FDA Filing Acceptance Of Supplemental New Drug Application For Tyvaso® For Pulmonary Hypertension Associated With Interstitial Lung Disease

Published: 2020-08-17 10:00:00 ET

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics expects the agency's review to be complete in April 2021.

"Tyvaso, if approved by the FDA, would be the first and only therapeutic approved for the treatment of PH-ILD, a condition that afflicts approximately 30,000 people in the United States," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "We look forward to working with the Agency during the regulatory review process, with the goal of expanding the population of patients with pulmonary hypertension who could benefit from this important medicine."

The sNDA is based on data from the phase 3 INCREASE clinical study of Tyvaso in adult patients suffering from World Health Organization (WHO) Group 3 PH-ILD. As previously announced on February 24, 2020, the INCREASE study met its primary endpoint as Tyvaso increased six-minute walk distance (6MWD) by 21 meters versus placebo (p=0.0043, Hodges-Lehmann estimate) after 16 weeks of treatment. In addition, the treatment difference in 6MWD at Week 16 was statistically significant when analyzed using Mixed Model Repeated Measurement (31 meters; P

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
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