Drugmaker to ‘challenge’ FDA after only receiving tentative approval for inhaled PAH treatment
Liquidia Corporation, a North Carolina-based biopharmaceutical company, has received tentative approval from the U.S. Food and Drug Administration (FDA) for the company’s treprostinil inhalation powder for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The FDA would have fully approved the new treatment, which will be sold and marketed under the brand name Yutrepia, but the agency said United Therapeutics is still in the middle of a three-year exclusivity period for its own dry-powder treprostinil offering, Tyvaso DPI. That exclusivity period is scheduled to last until May 23, 2025.
“We are pleased that the FDA agreed that our new drug application amendment last July was proper, providing a clear path to full approval of Yutrepia in both PAH and PH-ILD,” Roger Jeffs, PhD, CEO of Liquidia, said in a statement. “However, we are disappointed and disagree with the FDA’s decision to simultaneously grant regulatory exclusivity to United Therapeutics for Tyvaso DPI that encompasses chronic use of essentially any dry-powder formulation of treprostinil in the approved indications for a three-year period for its new dosage form approved on May 23, 2022. We plan to take quick action to challenge the FDA’s broad grant of regulatory exclusivity and defend the ability for patients to have access to Yutrepia with the least delay possible.”
The FDA’s decision to approve Yutrepia—tentatively, that is—was based largely on data from the INSPIRE trial, which explored the safety and effectiveness of the inhaled treatment in adult patients with PAH.[1] That study’s authors highlighted the medication’s “favorable safety profile and patient preference ratings,” concluding that inhaled Yutrepia represents a PAH treatment that “may be preferred by many patients based on its added convenience and potential to facilitate a more active lifestyle.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.