Tyvaso DPI Approved by the FDA for PAH and PH-ILD

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) has approved Tyvaso DPI, a dry powder, inhaled formulation of treprostinil, to improve exercise ability in people with pulmonary arterial hypertension (PAH) or pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Tyvaso DPI is now the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD, according to the therapy’s developer, United Therapeutics. The FDA had declined to approve Tyvaso DPI in October, citing an issue at a third-party manufacturing facility.

“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. We look forward to launching this exciting new product, and the opportunity to introduce treprostinil to more patients with PAH and PH-ILD,” Michael Benkowitz, United’s president and chief operating officer, said in a press release.

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Treprostinil is a vasodilator — a substance that prompts blood vessels to relax and widen, thus lowering blood pressure — that works by mimicking the activity of a naturally occurring signaling molecule called prostacyclin. Treprostinil had previously been available in several formulations, including Tyvaso (inhaled), Orenitram (oral), and Remodulin (infusion/injection).

All of these formulations are marketed by United, and all are approved to treat PAH. Tyvaso — and now Tyvaso DPI — are the only therapies approved by the FDA for PH-ILD, when blood pressure in the lungs is high due to a disease that causes lung scarring.

United applied to the FDA requesting approval of Tyvaso DPI last year. The application, which was given priority review, was supported by data from a Phase 1 clinical study called BREEZE (NCT03950739), in which 51 PAH patients who had been on stable treatment with the approved inhaled version of Tyvaso switched to Tyvaso DPI.

In addition to showing that the novel formulation was similarly safe as inhaled Tyvaso, results from BREEZE indicated that Tyvaso DPI led to improvement in exercise capacity, less patient-reported PAH symptoms and impact, and was more convenient for patients than the previously approved inhaled formulation.

“The convenience and portability of Tyvaso DPI may make it an important new option for patients with WHO Group 1 PAH and with WHO Group 3 PH-ILD, with the potential for improving the quality of life for this patient population,” said Shelley Shapiro, MD, PhD, from the David Geffen UCLA School of Medicine Pulmonary Hypertension Program.