TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

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TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.

TAKHZYRO Efficacy

Studied in one of the largest prevention studies in HAE with the longest active treatment duration1-5

Studied in one of the largest prevention studies in HAE with the longest active treatment duration1-5

Marie, a real TAKHZYRO® patient, dancing with her husband.
Marie
Al

TAKHZYRO was studied in a range of patients with HAE type I or II1,2

HELP study

Help Open-Label Extension Study

HELP Study

125
Patients1
  • 70% Female6
  • 30% Male6
  • 12 to 73 Years of Age7
6.5
Months
of active treatment
  • (26 weeks)1,6*
56%
previously treated
with long-term
preventive therapy
1
  • 48% were on C1-INH alone6
  • 3.2% were on oral therapy6†
  • 4.8% were on both6
52%
HAD ≥3 ATTACKS/‌MONTH DURING RUN-IN PERIOD1

*One month was defined as 28 days in the clinical trial. Androgens or antifibrinolytics.

Help Study Design

The clinical trial was a multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study, which assessed the safety and efficacy of TAKHZYRO in 125 patients with HAE type I or II (≥12 years of age). Patients were randomized to receive TAKHZYRO 150 mg every 4 weeks (n=28), TAKHZYRO 300 mg every 4 weeks (n=29), TAKHZYRO 300 mg every 2 weeks (n=27), or placebo (n=41) for 26 weeks (6.5 months, where 1 month was defined as 28 days). Prior to randomization, patients ≥18 years of age were required to complete a ≥2-week long-term prophylaxis washout period. All patients then entered a 4-week run-in period to determine the baseline HAE attack rate. Patients with ≥1 investigator-confirmed HAE attack during the run-in period were eligible for study enrollment and randomization. The primary efficacy endpoint was the rate of investigator-confirmed attacks during the treatment period (time frame: from Day 0 to Day 182).1,6

Rediscover prevention

Primary endpoints
Secondary endpoints
Exploratory endpoints

Significant reduction in mean attack rate‡ vs placebo at 6.5 months (26 weeks) in the pivotal trial1,6

  • TAKHZYRO every 4 weeks resulted in a 73% reduction in attacks vs placebo (Adjusted P<0.001)
  • Mean monthly attack rate at baseline (during run-in period): 3.52 for TAKHZYRO every 2 weeks (n=27); 3.71 for TAKHZYRO every 4 weeks (n=29); 4.02 for placebo (n=41)6
  • Mean monthly attack rate (during treatment): 0.26 for TAKHZYRO every 2 weeks; 0.53 for TAKHZYRO every 4 weeks; 1.97 for placebo1

Mean monthly attack rate: number of attacks/4 weeks.
§Adjusted P-values for multiple testing.

Down arrow icon.
87%
Reduction in Attacks
(Adjusted P<0.001)

with TAKHZYRO 300 mg every 2 weeks2

SELECT IMPORTANT SAFETY INFORMATION

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.

All secondary endpoints of the pivotal trial were met1,6

Primary endpoints
Secondary endpoints
Exploratory endpoints
Attack reduction vs placebo (Adjusted P<0.001)1,6||
Reduction in moderate or severe attacks
Reduction in attacks requiring acute treatment
TAKHZYRO 300 mg every 2 weeks (n=27)
83%
87%
TAKHZYRO 300 mg every 4 weeks (n=29)
73%
74%

||Adjusted P values for multiple testing.

Many patients had zero attacks1,6

Primary endpoints
Secondary endpoints
Exploratory endpoints

In a post hoc, exploratory analysis, after 6 doses (10 weeks) of TAKHZYRO (300 mg every 2 weeks):

NEARLY 8 OUT OF 10

PATIENTS
HAD ZERO ATTACKS
FOR THE NEXT 4 MONTHS
OF TREATMENT

77% of patients taking TAKHZYRO every 2 weeks (n=26) had zero attacks vs 3% of patients taking placebo (n=37) (Day 70 to Day 182).6

  • 45% of patients taking TAKHZYRO every 4 weeks (n=29) had zero attacks vs 3% with placebo (n=37) during steady-state period (Day 70 to Day 182)

Based on a prespecified exploratory analysis, over the entire 6.5-month study duration, 44% of patients taking TAKHZYRO every 2 weeks (n=27) had zero attacks vs 2% of patients taking placebo (n=41) (Day 0 to Day 182).1,6¶

  • 31% of patients taking TAKHZYRO every 4 weeks (n=29) had zero attacks vs 2% with placebo (n=41 for placebo) during the entire 6.5-month study (Day 0 to Day 182)1,6¶

Percentage of patients who had zero attacks over the entire 26-week study duration was a prespecified, exploratory endpoint. Percentage of patients who had zero attacks during the steady-state period (Day 70 to Day 182) was a post hoc analysis.

About 97% of patients in the HELP Study enrolled in the 2.5-year extension study2

HELP Open-label Extension Study

212
Patients2
  • 109 rollover patients, which represents about 97% of patients in the pivotal trial2
  • 103 nonrollover patients2
  • 81.6% of patients completed the study or enrolled in commercial product2
2.5
Years
of active treatment2
  • Patients were given TAKHZYRO 300 mg every 2 weeks for a mean duration of 29.6 (SD=8.2) months2
59%
previously treated
with long-term
preventive therapy
2
  • 50% were on C1-INH alone
  • 6.1% were on oral therapy*
  • 3.3% were on both
39%
HAD ≥3 ATTACKS/‌MONTH at baseline2

Long-term safety of TAKHZYRO was the primary endpoint in the open-label extension study.2

HELP Open-label Extension Study

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 this 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.2

*Androgens or antifibrinolytics. SD=standard deviation

Icon of pen.

Data were consistent in the open-label extension study1,2

Patients taking TAKHZYRO for an average of 30 months experienced attack reduction vs baseline2

Secondary endpoints
Prespecified exploratory endpoints
87%
Reduction
in Attacks
vs baseline (N=209)2
0.25
mean monthly
attack rate
(N=209; baseline: 3.05)2
0.05
median monthly
attack rate
(range: 0.0-4.7; baseline: 2.00)8
  • 84% reduction in moderate or severe attacks (N=209)2
  • 93% reduction in attacks requiring acute treatment (n=106)2

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

SELECT IMPORTANT SAFETY INFORMATION

The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea.


Many patients had zero attacks for extended periods of time when taking TAKHZYRO for an average of 30 months2

Secondary endpoints
Prespecified exploratory endpoints

On average, patients experiencedZero Attacks for

8 OUT OF 10

PATIENTS (81.8%)
FOR AT LEAST A
6-MONTH PERIOD

(N=209)2
98%

OF DAYS
ON AVERAGE DURING
treatment period

(N=209, SD=6%)2
  • 14.8 months was the mean duration of the attack-free period (415 days, SD=12.4 months) (N=209)2
  • Mean study duration: 29.6 months (SD=8.2)

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

Included rollover and nonrollover patients

SD=standard deviation.

Long-term data were consistent with the safety and efficacy in the pivotal trial.1,2

Marie, real TAKHZYRO® patient.

View a real patient case from the perspective of the treating HCP

Marie's frequent attacks led her to inquire about preventive treatment.

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Continue exploring TAKHZYRO

See safety information established in the pivotal trial and open-label extension study.

See Safety Profile

References: 1. TAKHZYRO (lanadelumab-flyo) [prescribing information]. Lexington, MA: Dyax Corp 2018. 2. Banerji A, Bernstein JA, Johnston DT, et al. Long-term prevention of hereditary angioedema attacks with lanadelumab: the HELP OLE Study. Allergy. Published online July 21, 2021. doi:10.1111/all.15011 3. CINRYZE (C1 esterase inhibitor [human]) [prescribing information]. Lexington, MA: Shire ViroPharma Incorporated; 2021. 4. HAEGARDA [prescribing information]. Kankakee, IL: CSL Behring LLC; 2020. 5. Orladeyo. Prescribing information. BioCryst Pharmaceuticals, Inc; 2020. 6. Banerji A, Riedl MA, Bernstein JA, et al. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018;320(20):2108-2121. doi:1001/jama.2018.16773 7. Data on file, DX-2930-03, Takeda Pharmaceuticals. 8. Data on file, TAK743-098, Takeda Pharmaceuticals.