A Phase 2/3, Open-Label, Repeat-Dose Study of the Pharmacokinetics, Efficacy, and Safety of ProMetic Plasminogen Intravenous Infusion in Subjects With Hypoplasminogenemia

Trial Profile

A Phase 2/3, Open-Label, Repeat-Dose Study of the Pharmacokinetics, Efficacy, and Safety of ProMetic Plasminogen Intravenous Infusion in Subjects With Hypoplasminogenemia

Completed
Phase of Trial: Phase II/III

Latest Information Update: 13 Oct 2017

At a glance

  • Drugs Plasminogen (Primary)
  • Indications Type I plasminogen deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors ProMetic Life Sciences
  • Most Recent Events

    • 13 Oct 2017 According to a ProMetic Life Sciences media release, the U.S Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its plasminogen replacement therapy (RyplazimTM) and granted a priority review status with a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018.
    • 11 Jul 2017 According to a ProMetic Life Sciences media release, in addition to the dossier filed with the FDA, the 48-week clinicalefficacy data from this trial will form the basis for the upcoming regulatory filing with Health Canada in the fourth quarter of 2017.
    • 11 Jul 2017 Long term data (n=10) from this trial published in a ProMetic Biosciences Media Release.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top