FDA accepts sBLA for Tyvaso

The US Food and Drug Administration has 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).

The drug’s developer, United Therapeutics (Nasdaq: UTHR), expects the agency's review to be complete in April 2021. The FDA approved the prostacyclin vasodilator in July 2009 for pulmonary arterial hypertension.

"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, chairman and chief executive of United Therapeutics, adding: "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."