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FDA Grants Tentative Approval for Liquidia’s YUTREPIA™ (Treprostinil) Inhalation Powder
First dry-powder formulation of treprostinil to meet criteria required for FDA approvalFinal FDA approval may occur in October 2022 or earlier upon resolution
About this update from Liquidia Corporation
[{"type":"text","content":"First dry-powder formulation of treprostinil to meet criteria required for FDA approvalFinal FDA approval may occur in October 2022 or earlier upon resolution of on-going litigationConference call and webcast scheduled for today at 9:00 a.m. Eastern Standard Time MORRISVILLE, N.C., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) granted tentative approval for YUTREPIA™ (treprostinil) inhalation powder, previously referred to as LIQ861. YUTREPIA is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. Tentative approval indicates that YUTREPIA has met all regulatory standards for quality, safety and efficacy required for approval in the United States. Dr. Tushar Shah, Chief Medical Officer of Liquidia, said: “We would like to take the opportunity to thank the patients and investigators who participated in the clinical development of YUTREPIA. 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.” The addressable market for inhaled treprostinil is significant and expected to grow. In 2020, United Therapeutics reported that its nebulized formulation of treprostinil indicated for PAH achieved sales of more than $480 million. The attributes of YUTREPIA including ease-of-use, convenience, direct lung delivery, and higher dosage range may not only make YUTREPIA a preference to nebulized therapy, but also an alternative to oral treatments, and possibly a treatment option to delay the use of parenteral therapies in PAH. There may also be future expansion opportunities for inhaled treprostinil into additional indications. Damian deGoa, Chief Executive Officer of Liquidia added: “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...