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United Therapeutics Pulls Plug On Trevyent Development

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Based on the FDA’s written comments, United Therapeutics Corporation (NASDAQ: UTHR) has decided to discontinue the development of Trevyent.

  • Trevyent is a drug-device combination product that combines two-day, single-use, disposable PatchPump technology with treprostinil for the subcutaneous treatment of pulmonary arterial hypertension.
  • The comments followed a meeting to discuss the company’s planned resubmission of its marketing application for Trevyent in light of a Complete Response Letter issued in April last year.
  • The FDA’s comments indicated that United Therapeutics would need to redesign the product to improve pump accuracy in certain respects and conduct a clinical study of the redesigned product.
  • Thus, the company will stop the development of Trevyent as it is no longer considered commercially reasonable.
  • Initially, the company submitted Trevyent application in September 2019.
  • The company expects to incur an impairment charge of roughly $107.3 million during the first quarter of 2021.
  • Price Action: UTHR shares are down 0.35% at $166 in premarket trading on the last check Wednesday.
 

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Posted-In: Phase 3Biotech News Health Care FDA General

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