United Therapeutics has announced the FDA’s approval of its NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics licensed Treprostinil Technosphere from MannKind Corporation in September 2018 and submitted the NDA for Tyvaso DPI in April 2021. The FDA accepted the NDA for priority review in June 2021 and issued a CRL in response to the NDA in October 2021.
United Therapeutics President and Chief Operating Officer Michael Benkowitz commented, “Tyvaso DPI is one of the easiest ways for patients to administer a prostacyclin, delivering the proven efficacy of treprostinil through a small inhaler that fits in the palm of the patient’s hand. We look forward to launching this exciting new product, and the opportunity to introduce treprostinil to more patients with PAH and PH-ILD.”
According to MannKind, the company is manufacturing Tyvaso DPI at its Connecticut facility and expects to have product available in June 2022. The dry powder treprostinil in Tyvaso DPI is based on MannKind’s Technosphere particle engineering technology and is delivered via MannKind’s Dreamboat inhaler. The approval is the second for a Technosphere DPI following the 2014 approval of MannKind’s Afrezza insulin DPI.
MannKind CEO Michael Castagna said, “We are elated that Tyvaso DPI has received approval from the FDA, which paves the way for patients to receive treprostinil in a new and convenient way. This approval exemplifies MannKind’s commitment to developing products that give people control of their health and the freedom to live life. With Tyvaso DPI, patients can potentially fit in the palm of their hand a full day of dosing treprostinil from a Dreamboat inhaler.”
Read the United Therapeutics press release.
Read the MannKind Corporation press release.
