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A clinical validation study of PatchPump used by Trevyent in healthy adult volunteers.

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A clinical validation study of PatchPump used by Trevyent in healthy adult volunteers.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Jul 2020

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At a glance

  • Drugs Treprostinil (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions

    • Most Recent Events

    • 29 Jul 2020 According to an United Therapeutics Corporation media release, the company is preparing NDA resubmission, which is expected to file in 2021.
    • 29 Apr 2020 According to an United Therapeutics Corporation media release, the FDA issued a complete response letter (CRL) related to our NDA indicating that some of the deficiencies previously raised by the FDA had not yet been addressed to its satisfaction. The company is evaluating the letter and will provide updates on plans to resubmit the NDA at a later date. The company has one year from the date of the CRL to resubmit our NDA to the FDA, which is expected to trigger a six-month review
    • 11 Sep 2019 According to a Correvio Pharma media release, that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Trevyent (treprostinil) for the treatment of pulmonary arterial hypertension (PAH). The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of April 27, 2020.

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