Press release
United Therapeutics Provides an Update on the Progress of the Tyvaso DPI™ New Drug Application
Draft label contains both PAH and PH-ILD indications; no contraindications and no boxed warning Complete response cites an open inspection issue at a
About this update from United Therapeutics Corporation
[{"type":"text","content":"Draft label contains both PAH and PH-ILD indications; no contraindications and no boxed warning\n Complete response cites an open inspection issue at a third-party analytical testing facility; no other deficiencies cited\n Approval and launch expected in summer 2022 or earlier\n\n\nSILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 18, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced an update on the U.S. Food and Drug Administration (FDA) review of the new drug application (NDA) for Tyvaso DPI™, for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), to improve exercise capacity. On Friday, October 15, 2021, the FDA issued a complete response declining to approve the NDA at this time. The FDA's letter noted only a single deficiency preventing approval of Tyvaso DPI, related to an open inspection issue at a third-party facility that performs analytical testing of treprostinil drug substance.\nIn addition, the FDA did not cite any deficiencies or issues related to operations performed at the MannKind Corporation facility for manufacture, testing, and packaging of finished Tyvaso DPI, including its associated device. All other requests from the agency have been addressed.\nThe draft labeling for Tyvaso DPI, as revised by FDA, includes the same indications as Tyvaso® (treprostinil) Inhalation Solution for PAH and PH-ILD, to improve exercise ability, and does not contain any contraindications or a boxed warning.\n\"We are very pleased with the FDA's feedback on the label, which will ultimately enable us to bring Tyvaso DPI to thousands of patients in need,\" said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. \"We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier.\"\n\"Tyvaso DPI will be a groundbreaking advancement for PAH and PH-ILD patients, and we look forward to launching this product no later than the summer of 2022,\" said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. \"We reaffirm the achievability of our near-term goal of doubling the number of patients on Tyvaso by the end of 2022, and our longer...