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An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110δ- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

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Trial Profile

An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110δ- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 25 Mar 2024

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At a glance

  • Drugs Leniolisib (Primary)
  • Indications Immunodeficiency disorders; Lymphadenopathy
  • Focus Adverse reactions; Registrational
  • Sponsors Pharming Group NV

    • Most Recent Events

    • 21 Feb 2023 According to Pharming Group NV media release, the company has received the positive opinion from the Europeans Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on the Pediatric Investigation Plan (PIP) for leniolisib as treatment for APDS in children.
    • 16 Feb 2023 According to Pharming Group N.V media release, based on the timetable for our responses, Pharming expects that CHMP will issue its opinion on the leniolisib MAA in 2H 2023.
    • 16 Feb 2023 According to Pharming Group N.V media release, the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has decided to shift its assessment of the Marketing Authorisation Application (MAA) for leniolisib to a standard review timetable. The company has received the list of questions from EMA which included a request to submit updated data from the ongoing long-term extension study collected after the interim analysis included in the original MAA.
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