Liquidia Submits Amendment To Add PH-ILD Indication To Tentatively Approved NDA For YUTREPIA (treprostinil) Inhalation Powder
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Liquidia has submitted an amendment to add PH-ILD indication to the tentatively approved NDA for YUTREPIA (treprostinil) Inhalation Powder. If approved by the FDA, YUTREPIA would be indicated for the treatment of both PH-ILD and pulmonary arterial hypertension (PAH). The FDA can grant final approval after the new clinical investigation exclusivity granted to Tyvaso® expires on March 31, 2024.
July 27, 2023 | 10:09 am
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Liquidia's amendment to add PH-ILD indication to YUTREPIA could expand its market if approved by the FDA. However, final approval can only be granted after March 31, 2024.
The news is directly related to Liquidia and its product YUTREPIA. If the amendment is approved, it could potentially expand the market for YUTREPIA, which would be positive for the company. However, the final approval can only be granted after March 31, 2024, which introduces a level of uncertainty.
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IMPORTANCE 80
RELEVANCE 100