FDA rejects United's potential PAH drug due to a manufacturing issue
United Therapeutics said Monday that it received a complete response letter for its potential pulmonary arterial hypertension drug Tyvaso DPI, due to an issue with a third-party facility that performs drug substance testing. The company said it expects an approval will come by next summer.
The inspection issue appears to be the only problem the FDA took notice of, according to United. There were no issues with packaging, manufacturing or testing Tyvaso DPI at the MannKind Corporation facility, the company 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,” said CEO Martine Rothblatt. “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.”
The company is looking to double the number of patients taking the drug by the end of next year, and have 25,000 patients using the product by the end of 2025.
But the FDA is still looking into a citizen’s petition submitted in July that concerns the safety of an inactive ingredient in Tyvaso DPI, though it did not cite that as a deficiency.
United got the OK from the FDA to sell the inhaled version of Tyvaso for pulmonary hypertension associated with interstitial lung disease in April.