FDA approved Tyvaso DPI (treprostinil) for Pulmonary Arterial Hypertension and PH-ILDFDA approved New Inhaled Drug for Two Types of Pulmonary Hypertension

FDA From the archive Source published May 23, 2022 Summary added September 29, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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The FDA has approved Tyvaso DPI (treprostinil) for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Tyvaso DPI is a prostacyclin mimetic administered via a dry powder inhaler in four separate treatment sessions per day.

The PAH indication is supported by studies with Tyvaso that predominantly included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). The PH-ILD indication is supported by a study that predominantly included patients with idiopathic interstitial pneumonia (45%), combined pulmonary fibrosis and emphysema (25%), and WHO Group 3 connective tissue disease (22%).

Nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor. The controlled clinical experience with Tyvaso was limited to 12 weeks in duration.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Tyvaso DPI is a prostacyclin mimetic. The label does not provide further mechanism details.

Indication & Patient Population

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%).

Tyvaso DPI is also indicated for the treatment of 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%).

Dosing & Administration

Use Tyvaso DPI only with the Tyvaso DPI Inhaler. Administer using a single inhalation per cartridge. Administer in 4 separate treatment sessions each day approximately 4 hours apart, during waking hours.

Initial dosage: one 16 mcg cartridge per treatment session. Dosage should be increased by an additional 16 mcg per treatment session at approximately 1- to 2-week intervals, if tolerated. Titrate to target maintenance doses of 48 mcg to 64 mcg per treatment session, 4 times daily.

If the prescribed dose is higher than 80 mcg per treatment session, more than 1 cartridge will be needed per session. Between each of the 4 daily treatment sessions, store the Tyvaso DPI Inhaler with the mouthpiece attached and empty. Wipe the outside of the inhaler with a clean, dry cloth only, if needed. Do not rinse or wash the Tyvaso DPI Inhaler; always keep the inhaler dry. After 7 days of use, throw away the used Tyvaso DPI Inhaler into regular household trash.

Dosage for Transition from Tyvaso (treprostinil) Inhalation Solution: The following regimens of Tyvaso DPI and Tyvaso give similar exposure: Tyvaso DPI 16 mcg corresponds to Tyvaso ≤5 breaths (≤30 mcg); 32 mcg to 6 to 7 breaths (36 to 42 mcg); 48 mcg to 8 to 10 breaths (48 to 60 mcg); 64 mcg to 11 to 13 breaths (66 to 78 mcg); 80 mcg to 14 to 15 breaths (84 to 90 mcg).

Key Clinical Trial Data

The label states that the controlled clinical experience with Tyvaso was limited to 12 weeks in duration. In PAH, TRIUMPH I was a 12-week, randomized, double-blind, placebo-controlled, multicenter study of patients with PAH (NCT00147199). The study population included 235 clinically stable subjects with PAH (WHO Group 1), nearly all with NYHA Class III (98%) symptoms who were receiving either bosentan or sildenafil for at least 3 months prior to study initiation. The primary efficacy endpoint was the change in 6MWD relative to baseline at 12 weeks. The label text provided does not include the results of this endpoint. For PH-ILD, the label references a study establishing effectiveness but does not provide detailed results in the provided text. Trial data not available in label for specific outcomes.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Tyvaso DPI is indicated for PAH (WHO Group 1) and PH-ILD (WHO Group 3) to improve exercise ability. Nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor. The effects diminish over the minimum recommended dosing interval of

The FDA has approved a new drug called Tyvaso DPI. It is a dry powder that you breathe in using a small inhaler. The drug is treprostinil, which helps open blood vessels in the lungs. It is approved for two conditions: pulmonary arterial hypertension (PAH) and pulmonary hypertension linked to interstitial lung disease (PH-ILD). Both are serious conditions that make it hard to exercise and can strain the heart.

This drug is for people who have one of these two types of pulmonary hypertension. In studies, it was mostly tested in patients who were also taking other heart and lung medicines. The main goal was to see if it improved how well patients could exercise. The approval gives doctors and patients another treatment choice.

One honest caveat: the studies only followed patients for about 12 weeks. So we do not yet know how well it works over a longer time. Also, Tyvaso DPI is not a cure. It may help with symptoms, but it does not reverse the disease.

If you or a loved one has pulmonary hypertension, talk with your doctor. Ask if this drug is right for you. Only your doctor can decide based on your full health picture.

What this means for you:

New inhaled drug approved for two types of pulmonary hypertension. Ask your doctor if it is right for you.

Study Details

Study typeFda approval

PublishedMay 2022

View Original Abstract ↓

1 INDICATIONS AND USAGE Tyvaso DPI is a prostacyclin mimetic 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%). ( 1.1 ) 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%). ( 1.2 ) 1.1 Pulmonary Arterial Hypertension 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%). The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities. While there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with Tyvaso was limited to 12 weeks in duration [see Clinical Studies (14) ] . 1.2 Pulmonary Hypertension Associated with ILD Tyvaso DPI is indicated for the treatment of 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%) [see Clinical Studies (14.3) ] .

FDA approved Tyvaso DPI (treprostinil) for Pulmonary Arterial Hypertension and PH-ILDFDA approved New Inhaled Drug for Two Types of Pulmonary Hypertension

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FDA approved Tyvaso DPI (treprostinil) for Pulmonary Arterial Hypertension and PH-ILDFDA approved New Inhaled Drug for Two Types of Pulmonary Hypertension

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