Safety profile in clinical trials for AJOVY

Adverse reactions reported by ≥2% of patients on AJOVY and greater than placebo1

AJOVY 225 mg Monthly (n=290) AJOVY 675 Mg Quarterly (n=667) Placebo Monthly (n=668)
Injection-site reactions* 43% 45% 38%

*Injection-site reactions include multiple adverse reactionsrelated terms, such as injection-site pain, induration, and erythema.

The safety of AJOVY was evaluated in two phase 3 clinical trials1

  • Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration1
  • AJOVY is fully humanized1
    • Humanization is a process designed to reduce immunogenicity2
    • Less than 1% of patients in both phase 3 trials developed antibodies to AJOVY3

 

≤2% of patients discontinued due to adverse events in both phase 3 trials in the AJOVY and placebo treatment arms3

 

Most injection-site reactions were rated as mild to moderate in severity3

In both phase 3 treatment arms,3

  • Less than 1% of patients experienced depression or weight gain vs <1% for placebo
  • No patients experienced memory loss vs <1% for placebo

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