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Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects

Trial Profile

Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Oct 2019

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At a glance

  • Drugs Mannitol (Primary)
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Pharmaxis
  • Most Recent Events

    • 28 Oct 2019 According to a Pharmaxis media release, the company has received detailed advice from the US Food and Drug Administration (FDA) on its plan to fulfil the requirements necessary to approve Bronchitol (mannitol) for the treatment of adult cystic fibrosis patients in the United States. Based on this feedback, the company has added an additional month to its timetable. The FDA review of the Bronchitol NDA is therefore now expected to be completed in the second quarter of 2020.
    • 20 Jun 2019 According to a Pharmaxis media release, the main requirement included in the FDA complete response letter is that Chiesi revise the product packaging and user instructions and then conduct a human factor study (HFS) demonstrating that the revised user components enable healthcare professionals to properly administer the mannitol tolerance test.This is targeted for completion by the end of 2019.
    • 20 Jun 2019 According to a Pharmaxis media release, the Chiesi Group (Chiesi) has received a complete response letter from the US Food and Drug Administration (FDA) detailing the remaining matters to be addressed before Bronchitol can be approved for adult cystic fibrosis (CF) patients in the United States. Based upon the clear and achievable path to approval communicated in the FDA complete response letter, Pharmaxis believes that the FDA review of the Bronchitol NDA will be completed in Q1 2020.
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