United Therapeutics Plans To Apply Priority Review Voucher To NDA For Tyvaso DPI

(RTTNews) - United Therapeutics Corporation (UTHR) has reached an agreement to acquire a Rare Pediatric Disease Priority Review Voucher for $105 million, which it plans to use with a forthcoming New Drug Application with the FDA. The PRV entitles the holder to designate an NDA for priority review. United Therapeutics plans to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.

Michael Benkowitz, Chief Operating Officer, said: "Once approved, Tyvaso DPI with the innovative Dreamboat device is expected to be a major advancement in the delivery of inhaled treprostinil therapy, offering substantial convenience compared to the existing Tyvaso nebulizer."