FDA decision on Yutrepia for PAH and PH-ILD due on May 24
Tentative approval given for US, but potential marketing rights awaited
The U.S. Food and Drug Administration (FDA) is poised to soon issue a final determination on Yutrepia, an inhaled dry powder formulation of treprostinil, up for approval to treat both pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).
The FDA granted Yutrepia tentative approval for PH-ILD last year and for PAH in 2021. These tentative approvals meant that the FDA judged that Yutrepia met all criteria for quality, safety, and efficacy, but the therapy was not able to be brought to market.
At issue was the fact that United Therapeutics had exclusive marketing rights for Tyvaso DPI, United’s inhaled dry powder formulation of treprostinil, which is currently the only version of the therapy approved in the U.S. United’s exclusivity period is set to expire on May 23, 2025. According to Liquidia, the developer of Yutrepia, the FDA has accepted a resubmission of an application seeking approval of the therapy, and announced an intent to make its final decision on Yutrepia public on May 24.
Treprostinil mimics the activity of hormone that widens blood vessels
“We are pleased that the FDA has responded promptly to the resubmission … We look forward to working with the FDA over the coming months as we seek final approval for Yutrepia and, in the meantime, will continue preparations to support a launch of Yutrepia as soon as possible,” Roger Jeffs, PhD, CEO of Liquidia, said in a company press release.
The active ingredient in Yutrepia, treprostinil, works by mimicking the activity of prostacyclin, which is a hormone that triggers blood vessels to relax and widen. The therapy aims to reduce blood pressure in the vessels of the lungs; both PAH and PH-ILD are marked by abnormally high pressure in lung blood vessels.
The FDA’s tentative approvals of Yutrepia were based on data from the Phase 3 clinical trial called INSPIRE (NCT03399604). The study tested Yutrepia in 121 people with PAH, including 66 who were not being treated with any form of inhaled treprostinil and 55 who had switched to Yutrepia from Tyvaso, which is nebulized treprostinil. Results showed that Yutrepia was generally safe and well tolerated, and the therapy led to improvements in measures of exercise capacity and quality of life.
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