The US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for inhaled treprostinil (Tyvaso DPITM) and granted it a priority review for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mannkind Corporation and United Therapeutics described the announcement as a significant milestone.
Michael Castagna, PharmD, chief executive officer of MannKind, said Tyvaso DPI provides patients a more convenient administration method for treprostinil therapy.
“A next-generation formulation of treprostinil, Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder, which was approved by the FDA in 2014,” the companies said in a press release.
The NDA comprised data from the BREEZE clinical study, a single-sequence study in which 51 subjects on a continuous treatment of Tyvaso inhalation solution were transitioned to Tyvaso DPI at a corresponding treprostinil dose. The study’s primary goal was to evaluate the safety and tolerability of Tyvaso DPI during a 3-week treatment phase in PAH patients previously treated with Tyvaso inhalation solution.
Out of the 51 subjects who participated in the study, 49 finished the treatment phase, and there were no study-related serious adverse events. The BREEZE study met its primary goal of exhibiting safety and tolerability in patients with PAH switching from Tyvaso inhalation solution to Tyvaso DPI.
Mannkind and United Therapeutics are also developing BluHale®, a Bluetooth-linked accessory for the Tyvaso DPI inhaler with a companion mobile application to help patients track data on their inhaler use.
MannKind, established in 1991 and headquartered in Westlake Village, California, focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases.
MannKind and United Therapeutics achieve a major milestone in the development of Tyvaso DPI™ with New Drug Application acceptance from the FDA. News release. Mannkind; June 16, 2021.United Therapeutics announces BREEZE study of investigational Tyvaso DPITM meets primary objective. News Release. United Therapeutics; Jan 28, 2021.