United Therapeutics Corporation (NASDAQ: UTHR) has offered an update on the US FDA review for its New Drug Application (NDA) for Tyvaso DPI for Pulmonary Arterial hypertension and pulmonary hypertension associated with interstitial lung disease treatment to boost exercise capacity.
FDA rejects Tyvasoi DPI NDA
The FDA released a detailed response on Friday, October 15, 2021, rejecting approval of the NDA at this time. The agency identified only one flaw in the latter. It was connected to an open inspection concern at a third-party facility that carries analytical testing of the treprostinil drug compound.
Furthermore, the FDA found no flaws or difficulties with the procedures done at the MannKind Corporation facility for the production, testing, and packing of finished Tyvaso DPI, as well as its associated device. All of the agency’s other requirements have been fulfilled.
Tyvaso DPI’s draft labeling, as revised by the FDA, includes the same indications as Tyvaso Inhalation Solution for PH-ILD and PAH to enhance exercise ability. Still, it doesn’t contain a boxed warning or any contraindications.
United Therapeutics anticipating the launch of Tyvaso by 2022
United Therapeutics CEO 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.”
Chief Operating Officer and President Michael Berkowitz commented, “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.”
