Yutrepia, Inhaled Treprostinil for PAH, Given Tentative Approval in US

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by Patricia Inacio, PhD |

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The U.S. Food and Drug Administration (FDA) has granted tentative approval to Yutrepia (treprostinil), previously known as LIQ861, as an inhalation treatment for pulmonary arterial hypertension (PAH), its developer Liquidia announced.

Tentative approval means that Yutrepia has met all regulatory standards regarding quality, safety, and efficacy required for approval in the U.S. Because of patent infringement allegations filed against the company, however, full approval — which allows for commercial use — may not be granted until at least late October, the company announced in a press release.

Liquidia’s first applied to the FDA for Yutrepia’s approval in April 2020, but the agency requested more data on the therapy and its use. An updated application, submitted in May, was accepted.

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The initial application was supported by findings from the Phase 3 INSPIRE clinical trial (NCT03399604), which showed that Yutrepia was safe and well-tolerated, and improved exercise capacity and quality of life in adults with PAH.

“We would like to take the opportunity to thank the patients and investigators who participated in the clinical development of Yutrepia,” Tushar Shah, MD, chief medical officer of Liquidia, said in the release.

“The tentative approval for YUTREPIA is another step toward providing an important option for patients with PAH in the U.S. We believe Yutrepia can improve the limitations of current nebulized therapies by allowing the administration of an expanded dose range of inhaled treprostinil using a proven, convenient, palm-sized device,” Shah added.

Yutrepia is a dry powder formulation of treprostinil, a vasodilator, administered using a portable inhaler. Of note, a vasodilator causes blood vessels to relax and widen, lowering blood pressure.

Manufactured using Liquidia’s proprietary PRINT technology, reported to allow for the production of highly uniform drug particles that are optimized for delivery into the lungs, Yutrepia is indicated for the treatment of PAH, namely to improve exercise capacity in adult patients with mild to severe symptoms.

“This is a significant milestone for Liquidia. We are really proud of our team. Not only does the tentative approval establish the safety and efficacy of Yutrepia for PAH patients but, in the process, we have validated our proprietary PRINT technology to engineer discrete drug particles with uniform composition, size, and shape,” said Damian deGoa, CEO of Liquidia.

Final FDA approval is excepted around Oct. 27, 2022, or earlier depending the outcomes of ongoing litigation.

United Therapeutics filed a lawsuit in June 2020 against Liquidia for alleged infringement of three patents related to Tyvaso, its inhaled treprostinil formulation approved in the U.S. to treat PAH patients categorized as WHO Group 1 PH.

The FDA cannot fully approve Yutrepia until the expiration of Tyvaso’s regulatory stay, which expires on Oct. 27, unless the litigation process is settled or otherwise resolved earlier.

“There is more work to be done. We will now focus our efforts on pre-commercial launch activities and the growing market opportunity for Yutrepia in PAH and potential new indications,” deGoa said.