Tyvaso Receives New Indication for Patients Who Have Interstitial Lung Disease

April 1, 2021 – The U.S. FDA has approved a new indication for Tyvaso® (treprostinil), manufactured by United Therapeutics, to treat patients who have pulmonary hypertension associated with interstitial lung disease (WHO group 3) to improve exercise ability.

Interstitial lung disease (ILD) is a group of diseases in which bronchioles and alveolar sacs of lungs develop significant scarring. This reduces the ability of the lungs to transport oxygen and produces symptoms such as shortness of breath, labored breathing, and fatigue. Pulmonary hypertension is an increase in blood pressure that affects the lungs and the heart and can cause additional complications for patients who have ILD. These can include a reduced ability to exercise, greater need for supplemental oxygen, lost quality of life, and worse health outcomes.

In a clinical study, patients treated with Tyvaso experienced significant improvement in six-minute walk distance (6MWD), as well as other measures of treatment success. Tyvaso is administered using the Tyvaso Inhalation System, which can be used at home. Initial recommended dosing is three breaths of Tyvaso per treatment session, four times daily. The dosage should then be increased by another three breaths per treatment session, four times daily, at approximately one - to two-week intervals. In clinical studies, target maintenance doses were 9-12 breaths per treatment session. If a patient experiences adverse effects that prevent the use of the target maintenance dose, Tyvaso should be continued at the highest tolerated dose.

Tyvaso first received FDA approval in 2009 to treat pulmonary arterial hypertension (WHO group 1) to improve exercise ability.