---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-22-064024"
form_type: "8-K"
ticker: "UTHR"
cik: "0001082554"
company_name: "UNITED THERAPEUTICS Corp"
filed_at: "2022-05-24T23:59:59+00:00"
generated_at: "2026-06-25T07:30:25.518257+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA approves United Therapeutics' Tyvaso DPI for PAH and PH-ILD; launch underway

## Summary
- FDA approved Tyvaso DPI (treprostinil inhalation powder) for PAH (WHO Group 1) and PH-ILD (WHO Group 3).
- First dry powder inhaler approved for PAH and PH-ILD; patient availability expected June 2022.
- BREEZE study (51 PAH patients) demonstrated safety/tolerance and improved 6-minute walk distance.
- TYVASO DPI and Tyvaso Inhalation Solution are only FDA-approved therapies for PH-ILD.
- Commercial launch activities underway, offering convenient treprostinil delivery via hand-held inhaler.

## SEC filing metadata
- accession: 0001104659-22-064024
- form_type: 8-K
- ticker: UTHR
- cik: 0001082554
- company_name: UNITED THERAPEUTICS Corp
- filed_at: 2022-05-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1082554/000110465922064024/0001104659-22-064024-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1082554/000110465922064024/tm2216671d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-22-064024
- JSON: https://secwatch.observer/filing/0001104659-22-064024.json
- Plain text: https://secwatch.observer/filing/0001104659-22-064024.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.