United Therapeutics says FDA accepts Tyvaso sNDA for idiopathic pulmonary fibrosis review
UTHR•Phase 3 data supporting the filing
The filing was supported by Phase 3 TETON-1 and TETON-2 data showing a 111.8 mL FVC benefit versus placebo at week 52.
FDA accepts Tyvaso supplemental filing
United Therapeutics said the FDA accepted a supplemental New Drug Application for nebulized Tyvaso to treat idiopathic pulmonary fibrosis.
The agency action starts a review targeted for completion in late April 2027.
