Tyvaso DPI FDA Approval History

Last updated by Judith Stewart, BPharm on June 1, 2022.

FDA Approved: Yes (First approved May 23, 2022)
Brand name: Tyvaso DPI
Generic name: treprostinil
Dosage form: Inhalation Powder
Company: United Therapeutics Corporation
Treatment for: Pulmonary Arterial Hypertension

Tyvaso DPI is a prostacyclin mimetic used for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

• Tyvaso DPI is a new dry powder inhalation formulation of Tyvaso, first approved as an inhalation solution formulation in 2009.
• Tyvaso DPI is indicated for the treatment of:
  • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with Tyvaso establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with Tyvaso establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).
• Tyvaso DPI is administered via the Tyvaso DPI Inhaler in 4 separate treatment sessions each day approximately 4 hours apart, during waking hours.
• Warnings and precautions include symptomatic hypotension, increased risk of bleeding, and bronchospasm.
• Common adverse reactions include cough, headache, throat irritation/pharyngolaryngeal pain, nausea, flushing, dyspnea, and syncope.

Development timeline for Tyvaso DPI

Further information

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