ACVYBRA® demonstrated comparable safety profile to the reference product in both incidence & severity of adverse events2

  • Comparable TEAE incidence*2
  • Comparable % of most common TEAEs**2
  • Low incidence of ISRs2

TEAEs, reported up to Month 12 (%)

TEAEs, reported from Month 12 to Month 18 (%)

hypocalcemia

NASOPHARYNGITIS

Upper respiratory tract infection

All ISRs were mild, except 1 moderate reaction (erythema + itching after ACVYBRA® injection).

*Across ACVYBRA® group, RP group and switch groups. This pattern held both from baseline to Month 12 and Month 12 to 18.
**Baseline to Month 12.TEAE: Treatment-Emergent Adverse Event; RP: Reference Product; ISR: Injection Site Reaction

ACVYBRA® demonstrated safety comparable to the reference product, including low immunogenicity and similar ADA & nAb profiles2

  • Comparable immunogenicity*2
  • ADA emergence similar across groups2
  • Low proportion of nAb positive participants2

Immunogenicity profiles:

  • Were similar across treatment groups through Month 12.
  • Remained consistent up to Month 18, including in those who
    underwent treatment switching.
  • Highest ADA incidence was
    observed between Months 2 and 3
    in both groups.
  • No new ADA development was observed between Months 12 and
    18 in any treatment group.
  • Low proportion of nAb-positive participants up to Month 12.
  • No new development of nAbs was observed from Month 12 to Month 18 in any treatment group.

ADA: Anti-DrugAntibodies; nAbs: Neutralizing Antibodies; RP: reference product