EMPOWER RWE Phase 4 study
EMPOWER 3-year findings were consistent with the overall safety profile for TAKHZYRO3
Six (4.3%) TEAEs in 2 (3.8%) patients were determined to be related to TAKHZYRO3
- In total, 58 of 112 patients in the safety analysis set reported 154 TEAEs. Of these 154 TEAEs, 6 (observed in 2 patients) were classified as related to TAKHZYRO3
TEAEs related to TAKHZYRO3
Number of Patients
Fatigue
3
Tachycardia
2
Papular rash
1
TEAE=treatment emergent adverse event.
- One new and one established patient discontinued TAKHZYRO due to TEAEs related to TAKHZYRO (papular rash and fatigue, respectively)3
EMPOWER RWE Phase 4 study
Additional safety information in the EMPOWER overall safety set
- There were no reports of injection site reactions related to TAKHZYRO in EMPOWER3
- Injection site reactions were the most commonly observed adverse reactions in ≥10% of patients in the phase 3 HELP clinical trial1
- TEAEs were mostly mild (66/154) or moderate (79/154) in severity, with 7 classified as severe3
- Most TEAEs were nonserious (146/154), with 8 considered serious3
Other TEAEs observed not classified as related to TAKHZYRO3
Events (# of patients)
Infections and infestations
43 events (34)
Gastrointestinal disorders
14 events (10)
General disorders and administration site conditions
11 events (6)
- Two patient deaths, which were unrelated to TAKHZYRO, occurred during the study (COVID-19 infection [n=1]; traumatic brain injury [n=1]).3
References: 1. Takhzyro. Prescribing information. Dyax Corp; 2025. 2. Banerji A, Riedl MA, Bernstein JA, et al. JAMA. 2018;320(20):2108-2121. doi:10.1001/jama.2018.16773 3. Bernstein JA, Betschel SD, Busse PJ, et al. Adv Ther. 2025;42(8):3882-3901. doi:10.1007/s12325-025-03226-3