Liquidia’s Inhaled Dry Powder Wins Tentative FDA Approval

Liquidia has grabbed tentative FDA approval for Yutrepia, the first inhalation powder form of treprostinil, a vasodilator used in other forms to treat pulmonary hypertension.

Yutrepia will be indicated for the treatment of pulmonary arterial hypertension to improve exercise ability in adult patients with New York Heart Association Functional Class II-III symptoms.

The new formulation is a big win for patients who currently rely on the liquid form administered through nebulization, Damian deGoa, the company’s CEO, said in a webcast. The drug is delivered in the RS00 — Model 8 capsule-based refillable single-dose dry powder inhaler.

The powder form will also allow greater doses than the nebulized formulation, deGoa said. In fact, the company has applied for a patent on powder doses of 100-300 mcg, he added.