About 97% of patients in the HELP study enrolled in the 2.5-year extension study⁵

TAKHZYRO is clinically proven to help prevent HAE attacks with every-2-weeks dosing that takes ≤1 minute to administer—patients experienced long-term freedom from attacks for an average of 14.8 (SD=12.4) months^1,5*†‡

^*In clinical studies, the majority of patients self-administered TAKHZYRO within 10 to 60 seconds.¹

^†Evaluated in a 6.5-month study and a 2.5-year open-label extension (OLE) study.^1,5

^‡Mean duration of the attack-free period in the OLE study was 14.8 (SD=12.4) months (N=209).⁵

SD=standard deviation.

HELP Open-Label Extension Study

• Patients were given TAKHZYRO 300 mg every 2 weeks for a mean duration of 29.6 (SD=8.2) months
• 81.6% of patients completed the study or enrolled in commercial product⁵

The open-label extension study evaluated the safety and efficacy of TAKHZYRO for up to 2.5 years in patients with HAE type 1 or type II (≥12 years of age). It included patients from the pivotal trial (rollover n=109) and additional patients (nonrollover n=103). In the long-term study, 212 patients received TAKHZYRO 300 mg every 2 weeks for a mean duration of 29.6 (SD=8.2) months. Most patients (81.6%) completed the study or enrolled in commercial product. For rollover patients, the HELP study baseline attack rate (4-week run-in period) was used as the baseline. For nonrollover patients, baseline was defined as the number of investigator-confirmed attacks reported in the last 3 months. Rollover patients, regardless of randomization group in the pivotal trial, received a single dose of TAKHZYRO 300 mg at study entry and were followed until the first HAE attack occurred. After the first HAE attack, all rollover patients received open-label treatment with TAKHZYRO 300 mg every 2 weeks. Nonrollover patients received open-label treatment with TAKHZYRO 300 mg starting on Day 0 and continued to receive TAKHZYRO every 2 weeks throughout the duration of the treatment period. The long-term safety of TAKHZYRO was the primary endpoint in the study.⁵

IN A 2.5-YEAR STUDY WITH OVER 200 PATIENTS, EFFECTIVE PREVENTION SHOWN IN THE LONG TERM⁵

Secondary Endpoints

Patients taking TAKHZYRO for an average of 30 months experienced HAE attack reduction vs baseline

Patients who experienced a reduction in frequency and severity of attacks in the HELP study (rollover patients) were more likely to choose to continue treatment with TAKHZYRO in HELP OLE, which may affect the interpretation of these data.

• 0.25 mean monthly attack rate (N=209; baseline: 3.05)⁵
• 0.05 median monthly attack rate (range: 0.0-4.7; baseline: 2.00)⁹
• 84% reduction in moderate or severe attacks (N=209)⁵
• 93% reduction in attacks requiring acute treatment (n=106)⁵
• All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.

SELECT IMPORTANT SAFETY INFORMATION
Adverse Reactions: The most commonly observed adverse reactions (≥10%) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; dizziness; diarrhea; and myalgia. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.

Prespecified Exploratory Endpoints

Freedom from attacks for extended periods of time when taking TAKHZYRO for an average of 30 months (N=209)⁵

ZERO ATTACKS FOR

All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.¹

*The percentage of days with zero attacks was calculated by counting the number of days in the treatment period without an HAE attack and dividing by the number of days the patient spent in the treatment period.⁹

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