Lymphangioleiomyomatosis Efficacy and Safety Trial

Trial Profile

Lymphangioleiomyomatosis Efficacy and Safety Trial

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Nov 2016

At a glance

  • Drugs Sirolimus (Primary)
  • Indications Lymphangioleiomyomatosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MILES
  • Sponsors Pfizer
  • Most Recent Events

    • 29 May 2015 According to a Pfizer media release, sirolimus (RAPAMUNE) has been approved by US FDA for the treatment of lymphangioleiomyomatosis.
    • 28 Apr 2015 According to a Pfizer media release, the supplemental NDA (sNDA) for sirolimus [Rapamune] for the treatment of lymphangioleiomyomatosis accepted by the FDA has a PDUFA (Prescription Drug User Fee Act) action date scheduled in June 2015.
    • 02 Mar 2015 New trial record
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