Summary

• Please refer to the local labeling for relevant information regarding immunogenicity with ICOTYDE.

COMPANY CORE DATA SHEET

Pharmacodynamic Effects

Immunogenicity

• As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.¹ 
• Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including concomitant medications and underlying disease. For these reasons, the incidence of antibodies to ICOTYDE in the studies described below should not be compared with the incidence of antibodies in other studies or to other products.¹ 
• In four Phase 3 clinical studies through Week 52, 9.6% (199/2083) of subjects treated with ICOTYDE developed antibodies to ICOTYDE. Of these subjects who developed antibodies to ICOTYDE, none had antibodies that were classified as neutralizing antibodies.¹ 
  • Among ICOTYDE-treated subjects who developed anti-drug antibodies, population pharmacokinetic analysis using pooled data through Week 52 showed that C_max and AUC increased by 1.2-fold and 1.3-fold, respectively, compared with subjects who did not develop anti-drug antibodies.
  • There was no identified clinically meaningful effect of anti-drug antibodies on pharmacokinetics, safety, or effectiveness of ICOTYDE through Week 52.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 5 February 2026.