A Multicenter, Open-Label Study of the Safety, Tolerability and Pharmacology of Asfotase Alfa in up to 10 Severely Affected Patients With for the Treatment of Severely Affected Patients With Infantile Hypophosphatasia (HPP)

Trial Profile

A Multicenter, Open-Label Study of the Safety, Tolerability and Pharmacology of Asfotase Alfa in up to 10 Severely Affected Patients With for the Treatment of Severely Affected Patients With Infantile Hypophosphatasia (HPP)

Completed
Phase of Trial: Phase I/II

Latest Information Update: 24 Feb 2016

At a glance

  • Drugs Asfotase alfa (Primary)
  • Indications Hypophosphatasia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Alexion Pharmaceuticals
  • Most Recent Events

    • 03 Nov 2015 Results published in the Journal of Clinical Endocrinology and Metabolism
    • 23 Oct 2015 According to an Alexion Pharmaceuticals media release, the US FDA has approved Strensiq (asfotase alfa) for the treatment of patients with perinatal-, infantile- and juvenile-onset hypophosphatasia (HPP).
    • 01 Sep 2015 According to an Alexion Pharmaceuticals media release, the European Commission has approved asfotase alfa (Strensiq) for long-term enzyme replacement therapy in patients with pediatric-onset hypophosphatasia (HPP) to treat the bone manifestations of the disease.
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