Liquidia and its dry powder Yutrepia is back in FDA limbo after the agency opted for a tentative approval as opposed to a standard nod.
While the FDA acknowledged that the drug, which is an inhalation powder designed to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), meets “all regulatory standards” for approval, Liquidia must wait until its competitor’s exclusivity clock runs out on May 23, 2025 to score final approval.
The competitor in question is United Therapeutics and its Tyvaso DPI. Both companies’ options are dry powder formulations of treprostinil, while their drug particle technologies are different. Tyvasvo’s recently-granted three-year exclusivity covers chronic use of “essentially any” dry powder formulation of treprostinil in the approved formulations following a new dosage strength that was approved in May 2022, Liquidia CEO Roger Jeffs, Ph.D., explained in a recent release.
“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,” Jeffs added.
The update follows a lengthy saga of litigation between United, Liquidia and the FDA itself.
Liquidia’s application for the dry powder drug was first accepted by the agency in 2020, then rejected with a complete response letter later that year before the FDA eventually granted tentative approval in 2021.
When the FDA later accepted Liquidia’s bid to add on a PH-ILD indication, United sued the regulator over claims that it allowed its competitor to sidestep “rules, precedents and procedures” by not requiring an entirely separate application for the new indication. United then sued Liquidia based on a recently acquired Tyvaso patent and filed for an injunction to prevent Yutrepia’s launch in PH-ILD.
The path to the latest tentative nod was paved in April when a judge in a Delaware district court removed an injunction that prevented the FDA from approving Yutrepia. Soon later, a judge over in a Washington, D.C. federal court rejected a motion for a temporary restraining order that United had filed for against the FDA.
United could have a blockbuster on its hands with Tyvaso DPI, with analysts at BTIG Research and Strategy previously predicting $1 billion in peak PAH usage and a potential $2 billion-plus opportunity in PH-ILD. The dry powder version picked up $731 million in sales for United in 2023.