December 28, 2020
United Therapeutics Corporation announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application with the U.S. Food and Drug Administration.
United Therapeutics advises the PRV entitles the holder to designate an new drug application for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.
“This acquisition affirms our commitment to bring a new generation of treatments to patients with pulmonary hypertension as quickly as possible,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “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.”
United Therapeutics has entered into a definitive agreement to purchase the PRV for $105 million. The closing of the transaction is subject to customary closing conditions, including obtaining expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976.