MannKind and United Therapeutics Earn FDA Priority Review Status
The FDA has granted priority review status for Tyvaso DPI as it seeks approval. Tyvaso DPI is a dry powder inhaled formulation of treprostinil to treat pulmonary arterial hypertension (PAH) as well as pulmonary hypertension associated with the interstitial lung disease (PH-ILD).
This priority review process shortens the FDA review period to eight months rather than an entire year.
United Therapeutics developed Tyvaso DPI and submitted the new drug application and request for priority review in April. MannKind Corp. developed the handheld Dreamboat inhalation device used to deliver Tyvaso DPI.
This collaboration works to deliver Tyvaso DPI to patients so that the drug may lower blood pressure and improve patient health. Over the course of initial Phase 1 trials, patients showed improvement in their ability to perform exercise and reduced PAH symptoms overall.
In anticipation of transitioning from manufacturing Dreamboats for a small clinical supply to a larger prelaunch inventory, MannKind is scaling up its R&D facility in Danbury, Connecticut.
“It’s exciting to bring growth and expansion to Danbury and the surrounding communities as MannKind continues to build upon its Technosphere technology,” said Joe Kocinsky, MannKind’s chief technology officer. “Our site will practically double in size as we spend the next months preparing for Tyvaso DPI, pending FDA approval.”
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