Idiopathic pulmonary fibrosis digest - 2021

Idiopathic pulmonary fibrosis digest - 2021

United Therapeutics enrolled first patient in Phase 3 TETON study

Tyvaso (Treprostinil (inhaled), Epoprostenol receptor agonist/ platelet aggregation inhibitor) – United Therapeutics/ Ascendis Pharma/ Ferrer/ Lee’s Pharmaceutical/ Mochida Pharmaceutical

  • In Mar’21, FDA approved Tyvaso for pulmonary hypertension associated with interstitial lung disease (PH-ILD) based on the Phase 3 INCREASE study
  • Based on the data from INCREASE study, United Therapeutics has initiated a Phase 3 TETON trial in idiopathic pulmonary fibrosis (IPF)
  • Trial details: TETON; Phase 3 in IPF; N=396; Inhaled treprostinil (6 mcg/breath) QID and titrated up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose; Primary outcomes: Absolute FVC; PCD: Jun’24; Recruiting; Location: US (For full story click here)

Enrollment was initiated in pivotal Phase 3 TETON study

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CI Scientists Commentary:

  • Post-hoc analysis data for PH-ILD (an umbrella term for fibrotic lung conditions that also includes IPF), revealed the positive benefit of Tyvaso in IPF
  • Based on this United Therapeutics quickly started a Phase 3 trial in a new indication
  • With proven benefits in IPF, United Therapeutics is expected to quickly complete this Phase 3 trial and file for an NDA. Regulatory review may also be expedited with existing FDA’s orphan drug designation for Tyvaso in IPF

– Dr. Kowndinya, CI Scientists

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