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A randomized, open-label, dose-ranging study to evaluate the pharmacokinetics and initial safety of subcutaneous and intramuscular natalizumab in subjects with multiple sclerosis

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Trial Profile

A randomized, open-label, dose-ranging study to evaluate the pharmacokinetics and initial safety of subcutaneous and intramuscular natalizumab in subjects with multiple sclerosis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Natalizumab (Primary) ; Natalizumab (Primary) ; Natalizumab (Primary) ; Immunomodulators
  • Indications Multiple sclerosis
  • Focus Pharmacodynamics; Pharmacokinetics; Registrational
  • Acronyms DELIVER
  • Sponsors Biogen Idec

    • Most Recent Events

    • 28 Apr 2021 According to a Biogen media release, the company has has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its supplemental Biologic License Application (sBLA) for a new subcutaneous (SC) route of administration of TYSABRI (natalizumab) to treat relapsing multiple sclerosis (MS). The CRL indicates that the FDA is unable to approve the company's filing as submitted. The company is evaluating the CRL and will determine next steps in the U.S.
    • 07 Apr 2021 According to a Biogen media release, based on data from the DELIVER and REFINE studies, the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI (natalizumab) to treat relapsing-remitting multiple sclerosis (MS).
    • 27 Feb 2021 Samples from this study were used for pharmacokinetic (PK)/pharmacodynamic (PD) model-based analyses, presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2021.
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