FDA has yet to confirm Yutrepia for pulmonary hypertension-ILD
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The FDA did not meet its Prescription Drug User Fee Act goal date that would extend Yutrepia as a treatment for patients with pulmonary hypertension associated with interstitial lung disease, according to a press release.
As noted in the release, Yutrepia (treprostinil, Liquidia Corporation) — an investigational, inhaled dry powder formulation of treprostinil — was tentatively approved for patients with pulmonary arterial hypertension (PAH) New York Heart Association functional class II and class III symptoms in November 2021.
Liquidia requested the addition of pulmonary hypertension (PH)-ILD to its new drug application for Yutrepia in July 2023.
In the 2024 update given to the company, the FDA said its review of the extension is ongoing. No additional clinical data from Liquidia was asked for in this update, according to the release.
Notably, the release said that United Therapeutics, another company developing/selling treatments for PAH and PH-ILD, has filed two complaints related to patent infringement against Yutrepia, but only one remains as of Jan. 22, 2024. United Therapeutics received FDA approval for its dry powder inhaler (Tyvaso) for PAH and PH-ILD in May 2022.
“We are in active communication with the FDA regarding the process we followed to amend our [new drug application] to add PH-ILD to the labeled indication,” Roger Jeffs, PhD, chief executive officer of Liquidia Corporation, said in the release. “Whether the [new drug application] is amended or supplemented, we will continue to prepare for the final FDA approval of Yutrepia to treat both PAH and PH-ILD patients following the expiration of regulatory exclusivity for Tyvaso on March 31, 2024.”
No new goal date for the Prescription Drug User Fee Act was announced in the FDA’s update to Liquidia.
Reference:
- FDA delays decision on extending Yutrepia to treat PH-ILD. https://pulmonaryhypertensionnews.com/news/fda-delays-decision-yutrepia-treat-ph-ild/. Published Jan. 26, 2024. Accessed Jan. 29, 2024.