United Therapeutics (UTHR), MannKind (MNKD) Announces FDA Acceptance of Tyvaso DPI NDA For Priority Review
- Wall Street surges to all-time closing high on earnings, economic revival
- Was Intel's (INTC) Second Quarter a Speedbump or Inflection?
- Twitter (TWTR) Gains After Beating Q2 Estimates, Analysts Raise PTs as Brand Recovery Accelerates
- U.S. dollar on track for second week of gains; Fed meeting in focus
- Snap (SNAP) Surges 17% After Smashing Q2 Views Across the Board to Yield a Dozen Price Target Hikes
Get inside Wall Street with StreetInsider Premium. Claim your 1-week free trial here.
United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics expects the agency's review to be complete in October 2021. FDA also indicated that they have not identified any potential review issues at this time.
Tyvaso DPI is a next-generation dry powder formulation of Tyvaso. If approved, Tyvaso DPI is expected to provide a more convenient method of administration as compared with traditional nebulized Tyvaso therapy.
"The acceptance of the Tyvaso DPI NDA for review represents an important regulatory step toward offering this meaningful new product to both PAH and PH-ILD patients," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "If approved, Tyvaso DPI will represent yet another path to help us achieve our goal of serving 25,000 patients by the end of 2025."
The NDA includes data from the BREEZE study that demonstrated safety and tolerability of Tyvaso DPI in patients with PAH transitioning from Tyvaso® (treprostinil) Inhalation Solution. A separate study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution.
In its communications with United Therapeutics, the FDA indicated that approval of the NDA will be subject to an inspection of the Tyvaso DPI manufacturing facility operated by MannKind Corporation; FDA and MannKind have jointly targeted the third quarter of 2021 to complete the inspection.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Pfizer (PFE) And BioNTech SE (BNTX) Announces Additional 200M Vaccine Order from US Government
- Tonix Pharma (TNXP) Says Interim Analysis Shows TNX-102 SL Unlikely to Demonstrate Statistically Significant Improvement, Enrollment Stopped
- U.S. CDC advisers back J&J COVID-19 vaccine benefits amid neurological illness reports
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!