Liquidia's Yutrepia Cleared for Potential FDA Approval Following Court Ruling

By Denny Jacob

Liquidia's new drug application for yutrepia is cleared for potential approval from the U.S. Food and Drug Administration following a court ruling in a lawsuit filed by United Therapeutics.

Judge Andrews of U.S. District Court for the District of Delaware set aside the injunction issued in August 2022 in the lawsuit filed by United Therapeutics. As a result, the FDA is no longer enjoined from issuing final approval of the new drug application for yutrepia.

The FDA tentatively approved yutrepia to treat pulmonary arterial hypertension in November 2021. Liquidia in July amended its application to add the indication treat pulmonary hypertension associated with interstitial lung disease.

United Therapeutics filed a notice of appeal with respect to Judge Andrews' decision to set aside the injunction. It also filed two separate lawsuits in which it's seeking to obtain new injunctions to prevent launch of yutrepia for the treatment of pulmonary hypertension associated with interstitial lung disease.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

April 01, 2024 06:37 ET (10:37 GMT)

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