BAQSIMI™ (glucagon) nasal powder: Immunogenicity

Detailed Information

As with all therapeutic peptides, there is the potential for immunogenicity with Baqsimi.¹

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody, including neutralizing antibody, positivity in an assay may be influenced by several factors including

• assay methodology

• sample handling

• timing of sample collection

• concomitant medications, and

• underlying disease.¹

For these reasons, comparison of incidence of antibodies to Baqsimi with the incidences of antibodies to other products may be misleading.¹

In 3 clinical trials, 3/124 (2%) of participants treated with Baqsimi had treatment-emergent anti-drug antibodies as detected by an affinity capture elution ligand-binding immunogenicity assay. No neutralizing antibodies were detected.¹

Enclosed Prescribing Information

BAQSIMI™ (glucagon) nasal powder, for intranasal use, Lilly

Reference

1. Baqsimi [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

Glossary

Baqsimi = Baqsimi™ (glucagon) nasal powder