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United Therapeutics Says Tyvaso DPI Gets FDA Approval

United Therapeutics Corp. (UTHR), a public benefit corporation, announced Tuesday that the U.S. Food and Drug Administration has approved Tyvaso DPI (treprostinil) inhalation powder.

The approval is for the treatment of pulmonary arterial hypertension or PAH and pulmonary hypertension associated with interstitial lung disease or PH-ILD to improve exercise ability.

Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.

The FDA's decision is based on data from BREEZE, an open label study of 51 PAH patients on a stable regimen of Tyvaso Inhalation Solution who were transitioned to Tyvaso DPI.

PAH is life-threatening high blood pressure in the arteries of the lungs, affecting the ability of the heart and lungs to work properly.

The company noted that Tyvaso (treprostinil) Inhalation Solution and Tyvaso DPI are the only therapies approved by the FDA to treat PH-ILD.

According to the company, Tyvaso DPI is one of the easiest ways for patients to administer a prostacyclin, delivering the proven efficacy of treprostinil through a small inhaler that fits in the palm of the patient's hand.

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