United Therapeutics said that it has submitted an NDA for its Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and has applied a priority review voucher that it acquired for $105 million in December 2020. With the use of the priority review voucher, the FDA could issue a decision regarding the NDA by the end of 2021.
In 2018, United Therapeutics announced that it had licensed the dry powder treprostinil formulation from MannKind. Earlier this year, the company had announced that the BREEZE clinical study demonstrated that PAH patients can safely switch from Tyvaso treprostinil inhalation solution to the Tyvaso DPI. Tyvaso DPI is delivered via MannKind’s Dreamboat dry powder inhaler, which is the same device used for delivery of MannKind’s Afrezza inhaled insulin. The company said that a version of Mannkind’s BluHale inhaler monitoring device is in development for the Tyvaso DPI.
United Therapeutics Senior VP, Product Development, Leigh Peterson said, “In the BREEZE and pharmacokinetic studies, Tyvaso DPI demonstrated safety, tolerability, and a comparable pharmacokinetic profile to nebulized Tyvaso Inhalation Solution. If approved by the FDA, we expect Tyvaso DPI will provide an advancement in the delivery of inhaled treprostinil therapy.”
Chief Medical Officer Gil Golden added, “Since our founding, we’ve worked hard to ensure our patients have ample choices to deliver treprostinil in various ways to suit their individual needs. If approved, Tyvaso DPI will enable patients to go about their day with just a small breath-actuated, dry powder inhaler that easily fits inside a pocket and requires no batteries or external power source to operate.”
President and Chief Operating Officer Michael Benkowitz commented, “We’re excited for the potential for Tyvaso DPI to be one of our next product launches, assuming a timely approval in December of this year. The patient choice afforded by Tyvaso DPI, if approved, will help us achieve our goal of doubling the number of patients on Tyvaso therapy by the end of 2022. We remain committed to investigating, innovating, and delivering multiple therapies and treatments designed to help our patients manage their conditions.”
Read the United Therapeutics press release.
