MannKind Says FDA Grants Priority Review For Tyvaso DPI NDA

MannKind Corp. (MNKD) and United Therapeutics Corp. (UTHR) Wednesday announced that the U.S. Food and Drug Administration accepted for priority review of the New Drug Application for Tyvaso DPI (inhaled treprostinil) for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Shares of MannKind gained over 6%, following the news.

The development marks the second compound formulated with MannKind's Technosphere technology to be reviewed by the FDA, which is expected to be complete in October 2021. The FDA has also indicated that they have not identified any potential review issues at this time.

MannKind and United Therapeutics entered into a worldwide exclusive licensing and collaboration agreement in September 2018 for the development and commercialization of Tyvaso DPI.

The company said it expects the agency's review to be complete in October.

The FDA indicated that approval of the new drug application will be subject to an inspection of the Tyvaso DPI manufacturing facility operated by MannKind. FDA and MannKind have jointly targeted the third quarter of 2021 to complete the inspection.

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