United Therapeutics starts litigation with FDA over rival Liquidia's drug application

[February 22, 2024]  (Reuters) -United Therapeutics said on Wednesday it had filed a case with the U.S. Food and Drug Administration, alleging that due procedure was not followed in allowing rival Liquidia's application for a blood pressure drug.

United Therapeutics alleged that Liquidia skirted long standing FDA rules, precedents and procedures when it filed its application for an inhaled dry powder of treprostinil for pulmonary hypertension associated with interstitial lung disease (PH-ILD).

PH-ILD is a group of disorders that cause scarring in the lungs.

United Therapeutics has also sued Liquidia for patent infringement of its drug Tyvaso.

Liquidia said last month the FDA was still reviewing its drug, decision on which was due on Jan. 24.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

Both the FDA and Liquidia declined to comment on the ongoing litigation.

(Reporting by Leroy Leo and Christy Santhosh in Bengaluru; Editing by Shinjini Ganguli)

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