US Food and Drug Administration approves YUTREPIA, a treprostinil inhalation powder for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease

Yutrepia is a dry powder formulation of treprostinil, a prostacyclin analog. It is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort. Yutrepia was was tentatively approved by the Food and Drug Administration last year (see our article here), but the agency was waiting for regulatory exclusivity of a competing product to expire before granting full approval. The approval was based on the results of the phase 3 INSPIRE study.

YUTREPIA is approved for pulmonary arterial hypertension (Group 1 of the World Health Organisation pulmonary hypertension classification) and for pulmonary hypertension associated with interstitial lung diseases, PH-ILD (Group 3 of the World Health Organisation pulmonary hypertension classification). See also our dedicated section on the classification of pulmonary hypertension here

Read more on the company press release at this link

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