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- MannKind Corporation (NASDAQ:MNKD) has lost ~18.1% in the pre-market after United Therapeutics (NASDAQ:UTHR) failed to win FDA approval for Tyvaso DPI.
- With the New Drug Application (NDA), United (UTHR) sought to market the product for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), to improve exercise capacity.
- The regulatory setback relates to an inspection issue at a third-party testing facility for treprostinil drug substance, the active ingredient of Tyvaso DPI.
- However, in the complete response, the FDA had not cited any issues related to operations at MannKind’s (MNKD) facility in Connecticut for manufacturing, testing, and packaging of finished Tyvaso DPI.
- "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," remarked United Therapeutics CEO Martine Rothblatt.