Sangana, Ramachandra, Yan, Xu, Shah, Bharti, Tian, Xianbin, Zack, Julia, Shakeri-Nejad, Kasra, Sampath, Kalluri, Jones, Ieuan, Ligueros-Saylan, Monica, Fowler Taylor, Angel, Jain, Devendra Kumar, Scosyrev, Emil, Uddin, Molla, Laurent, Nathalie and Paola, Paganoni (2024) 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. Clinical Pharmacology in Drug Development, 13 (6). pp. 611-620. ISSN 2160-763X2160-7648

Abstract

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 (i) new PFS with autoinjector (PFS-AI), (ii) new PFS-NSD configuration, and (iii) 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 (Cmax), area under the concentration-time curve until the last quantifiable measurement (AUClast), and AUC extrapolated to infinity (AUCinf). Safety was assessed throughout the study. In total, 193 healthy volunteers were randomized at 1:1:1 ratio to omalizumab 1x300mg/2mL via new PFS-AI (n=66), omalizumab 1x300mg/2mL via new PFS-NSD (n=64), or omalizumab 2x150mg/1mL via current PFS-NSD (n=63). Comparing new PFS-AI versus current PFS-NSD, the GMRs (95% CIs) were: Cmax, 1.085 (0.996–1.181); AUClast, 1.093 (0.997–1.199); AUCinf, 1.100 (1.001–1.209). Comparing new PFS-NSD versus current PFS-NSD, the GMRs (95% CIs) were: Cmax, 1.006 (0.923–1.096); AUClast, 1.016 (0.925–1.116); AUCinf, 1.027 (0.933–1.130). 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.

Item Type:	Article
Keywords:	Omalizumab, pharmacokinetics, bioequivalence, autoinjector
Date Deposited:	15 Oct 2024 00:45
Last Modified:	15 Oct 2024 00:45
URI:	https://oak.novartis.com/id/eprint/33655