Liquidia working to bring Yutrepia to US market after FDA approval
New therapy designed to treat PH with interstitial lung disease as well as PAH
Soon after Yutrepia (treprostinil) was approved by the U.S. Food and Drug Administration (FDA) to treat some forms of pulmonary hypertension, the therapy’s maker, Liquidia, scheduled its first commercial shipment to specialty pharmacies.
“We have moved with exceptional speed to provide a new and differentiated therapeutic alternative to the marketplace,” Roger Jeffs, PhD and CEO of Liquidia, said in a company press release. “In just over one week, our sales force hit the ground running with the promotion of YUTREPIA … and commercial product was shipped to specialty pharmacies.”
Yutrepia was approved by the FDA in late May as a treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). Both are forms of pulmonary hypertension, where pressure in the vessels that carry blood from the heart through the lungs is abnormally high, putting strain on the heart.
Yutrepia is an inhaled dry powder formulation of treprostinil, a medication that works by mimicking the activity of a naturally occurring hormone called prostacyclin. This hormone triggers blood vessels to relax and widen, thereby reducing blood pressure.
“This extraordinary pace is a direct result of our rigorous preparation and the strategic urgency driving our desire to provide patients immediate access to the unique attributes of Yutrepia as we look to position it as the prostacyclin of first choice for patients with PAH and PH-ILD,” Jeffs added.
Although Yutrepia had been approved by the FDA, there was some uncertainty regarding when it could be brought to market because of a legal entanglement with United Therapeutics. United had filed a complaint against Liquidia, alleging that Yutrepia would infringe on patent protections for Tyvaso DPI, United’s own inhaled dry powder formulation of treprostinil.
United had filed motions in court requesting a preliminary injunction and a temporary restraining order, which would effectively stop Yutrepia from being brought to market until the legal issues are resolved. But the U.S. District Court for the Middle District of North Carolina denied these requests on May 30.
According to Liquidia, the court based its denial in part on the conclusion that United’s claims are not likely to succeed. The court’s denial means that there are no longer any legal obstacles preventing Liquidia from bringing Yutrepia to market.
Liquidia has filed a motion to dismiss, stay, or transfer United’s patent claims, which remain pending.
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