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Important Safety Information
Full Prescribing Info

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

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

TAKHZYRO Efficacy

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

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 study open label extension

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 therapy1
  • 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

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)1§
  • 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)7
  • 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.

87%
Reduction in Attacks
(Adjusted P<0.001)1§

Data presented above is for TAKHZYRO 300 mg every 2 weeks.

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

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 attacks

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

NEARLY OUT OF

PATIENTS HAD ZERO ATTACKS

FOR THE NEXT 4 MONTHS
OF TREATMENT6¶

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)6¶

Based on an 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.

HELP Study Open Label Extension

212
Patients2
  • 109 rollover patients, which represents about 97% of patients in the pivotal trial1,2
  • 103 nonrollover paitents1
  • At the time of this interim analysis, most patients (87.7%) were still enrolled in this study2
≤2.5
Years
of active treatment1
  • In this interim analysis, patients were given TAKHZYRO 300 mg every 2 weeks for a mean duration of 19.7 (SD=5.3) months2
59%
previously treated
with long-term
preventive therapy2
  • 50% were on C1-INH alone
  • 5.7% were on oral therapy*
  • 43.3% were on both
39%
HAD ≥3 ATTACKS/‌MONTH at baseline2

Help Study Open Label Extension

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 this interim analysis, 212 patients received TAKHZYRO 300 mg every 2 weeks for a mean duration of 19.7 (SD: 5.3) months. At the time of this analysis, most patients (87.7%) were still enrolled in this study. 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 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.1,2,6,8

*Androgens or antifibrinolytics.
SD=standard deviation

Long-term open-label extension study followed more than 200 patients1,2

In this interim analysis of prespecified, exploratory endpoints of patients taking TAKHZYRO for an average of ~20 months2,6

87%
Reduction in Attacks
Compared to baseline attack rate
(n=204)2
0.26
MEAN MONTHLY ATTACK RATE
(n=209; baseline: 3.05)2
0.05
MEDIAN MONTHLY ATTACK RATE
(range: 0.0-4.7; baseline: 2.00)2
  • 84% reduction in moderate or severe attacks (n=172)2
  • 93% reduction in attacks requiring acute treatment (n=94)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.

In prespecified, exploratory endpoints from the interim analysis, many patients taking TAKHZYRO were attack free for a defined period of time2

ON AVERAGE, PATIENTS EXPERIENCED

98%

OF DAYS WITH
ZERO ATTACKS
during treatment period†(n=209, SD=6%)2

  • Mean monthly attack rate at baseline was 3.05

†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.

NEARLY8 OUT OF10

PATIENTS HAD
ZERO ATTACKS

FOR AT LEAST A 6-MONTH PERIOD2

  • 78% of patients taking TAKHZYRO had zero attacks for at least a 6-month period (n=209)2

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

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

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Jason started TAKHZYRO after only being treated with acute therapy.

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Continue exploring TAKHZYRO

See safety information established in the pivotal trial and long-term study.

See Safety Profile

INDICATION

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

IMPORTANT SAFETY INFORMATION

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

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

Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.

No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.

To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-FDA-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

INDICATION

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

IMPORTANT SAFETY INFORMATION

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

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

Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.

No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.

To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-FDA-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

References: 1. TAKHZYRO (lanadelumab-flyo) [prescribing information]. Lexington, MA: Dyax Corp 2018. 2. Data on file, TAK743-096, Takeda Pharmaceuticals. 3. CINRYZE (C1 esterase inhibitor [human]) [prescribing information]. Lexington, MA: Shire ViroPharma Incorporated; 2018. 4. HAEGARDA [prescribing information]. Kankakee, IL: CSL Behring LLC; 2017. 5. Craig T, Zuraw B, Longhurst H, et al. Long-term outcomes with subcutaneous C1-inhibitor replacement therapy for prevention of hereditary angioedema attacks. J Allergy Clin Immunol Pract. 2019;7(6):1793-1802.e2. 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, SHP643-066, Shire Inc. 8. Riedl MA, Bernstein JA, Craig T, et al. An open-label study to evaluate the long-term safety and efficacy of lanadelumab for prevention of attacks in hereditary angioedema: design of the HELP study open label extension. Clin Transl Allergy. 2017;7:36. Doi:10.1186/s13601-017-0172-9.