Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers.

Autor: Sangana R; Novartis Institutes for Biomedical Research, Cambridge, MA, USA., Xu Y; Genentech Research and Early Development, South San Francisco, CA, USA., Shah B; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Tian X; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Zack J; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Shakeri-Nejad K; Novartis Pharma AG, Basel, Switzerland., Kalluri S; Novartis Healthcare Pvt, Hyderabad, India., Jones I; Novartis Pharma AG, Basel, Switzerland., Ligueros-Saylan M; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Taylor AF; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Jain DK; Novartis Pharma AG, Basel, Switzerland., Scosyrev E; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Uddin A; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Laurent N; Novartis Pharma AG, Basel, Switzerland., Paganoni P; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Jazyk: angličtina
Zdroj: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Jun; Vol. 13 (6), pp. 611-620. Date of Electronic Publication: 2024 Feb 22.
DOI: 10.1002/cpdd.1373
Abstrakt: Omalizumab is an anti-IgE monoclonal antibody currently approved for the treatment of asthma, nasal polyps/chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Omalizumab is available as an injection in a prefilled syringe (PFS) with a needle safety device (NSD). New product configurations were developed to reduce the number of injections per dose administration, improve patient convenience and treatment compliance. The objective of this randomized open-label 12-week study was to demonstrate pharmacokinetic bioequivalence between (1) new PFS with autoinjector (PFS-AI), (2) new PFS-NSD configuration, and (3) current PFS-NSD configuration. Each new configuration was considered bioequivalent to the current configuration if the confidence intervals (CIs) for the geometric mean ratios (GMR) were contained in the 0.80-1.25 range for maximum concentration (C max ), area under the concentration-time curve until the last quantifiable measurement (AUC last ), and AUC extrapolated to infinity (AUC inf ). Safety was assessed throughout the study. In total, 193 healthy volunteers were randomized at 1:1:1 ratio to omalizumab 1×300 mg/2 mL via new PFS-AI (n = 66), omalizumab 1×300 mg/2 mL via new PFS-NSD (n = 64), or omalizumab 2×150 mg/1 mL via current PFS-NSD (n = 63). Comparing new PFS-AI versus current PFS-NSD, the GMRs were: C max , 1.085; AUC last , 1.093; AUC inf , 1.100. Comparing new PFS-NSD versus current PFS-NSD, the GMRs were: C max , 1.006; AUC last , 1.016; AUC inf , 1.027. The 95% CIs for all GMR parameters were contained within the 0.80-1.25 range. Safety findings were consistent with the known safety profile of omalizumab. Single-dose omalizumab administered as the new PFS-AI or new PFS-NSD was bioequivalent to the current PFS-NSD.
(© 2024 Novartis Pharmaceuticals. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.)
Databáze: MEDLINE
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