Liquidia Corporation (NASDAQ: LQDA) has announced that the FDA has granted YUTREPIA (treprostinil) inhalation powder tentative approval.
YUTREPIA indicated for PAH treatment
YUTREPIA, which was previously called LIQ861, is indicated for pulmonary arterial hypertension treatment. This tentative approval shows that YUTREPIA has met all necessary safety, efficacy, and quality standards for approval in the US.
Liquidia Chief Medical Officer Dr. Tushar Shah 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.”
Inhaled treprostinil offers direct lung administration
Inhaled treprostinil has a sizable addressable market that is predicted to grow. Last year United Therapeutics reported sales of around $480 million for its nebulized treprostinil formulation approved for PAH. The direct lung administration, convenience, ease-of-use, and higher dosage range of YUTREPIA may make it a better alternative to nebulized therapy, as well as an alternative to oral medications. It could also be a treatment option to delay the usage of parenteral therapies in PAH. There may be future potential to expand the use of inhaled treprostinil to new indications.
CEO of Liquidia Damian deGoa said, “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. 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.”
Because of regulatory stay as per the Hatch-Waxman Act, YUTREPA can’t be marketed in the US until October 27, 2022.
