United Therapeutics said that the FDA has issued a complete response letter regarding the company’s NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics licensed Treprostinil Technosphere from MannKind in September 2018 and submitted an NDA for Tyvaso DPI in April 2021. The FDA accepted the NDA for priority review in June 2021.
The complete response letter also indicates that the FDA is continuing to review a citizen petition that was filed in July 2021 “concerning the safety of an excipient in Tyvaso DPI,” the company said. United Therapeutics is also involved in litigation with Liquidia Corporation, which received a CRL for its LIQ861 treprostinil DPI in November 2020 and resubmitted its application in May 2021.
According to the United Therapeutics, the agency did not cite any issues related to MannKind’s manufacturing, testing, and packaging facility where the finished Tyvaso DPI is produced, and the only deficiency cited in the letter is related to a contract facility that does analytical testing of the treprostinil drug substance. The company also noted that following FDA revisions, the draft label for the DPI includes the same indications as for Tyvaso inhalation solution, and the agency has not required a boxed warning or listed any contraindications.
United Therapeutics CEO and Chair Martine Rothblatt said, “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. 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.”
President and Chief Operating Officer Michael Benkowitz added, “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. 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-term goal of having 25,000 patients on our products by the end of 2025.”
Read the United Therapeutics press release.
