TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.
THE LARGEST PREVENTION STUDY IN HAE WITH THE LONGEST ACTIVE TREATMENT DURATION1-3
SEE RESULTSTAKHZYRO was studied in a range of patients with HAE type I or II1
PATIENTS1
- 70% female
- 30% male
- 12 to 73 years of age
MONTHS
of active treatment
(26 weeks)1,4*
PREVIOUSLY
TREATED
with long-term
preventive therapy1,4
- 48% were on C1-INH alone
- 3.2% were on oral therapy†
- 4.8% were on both
HAD ≥3 ATTACKS/
MONTH DURING
RUN-IN PERIOD1
-
Clinical trial 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).1,4
*One month was defined as 28 days in the clinical trial.4
†Androgens or antifibrinolytics.4
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.
REDISCOVER PREVENTION
Mean monthly attack rate at baseline (during run-in period): 3.52 for TAKHZYRO (n=27); 4.02 for placebo (n=41)4
Primary endpoint: significant reduction in mean attack rate‡ with TAKHZYRO 300 mg every 2 weeks vs placebo at 6.5 months (26 weeks)1,4
(Adjusted P<0.001)1§
Mean monthly attack rate (during treatment): 0.26 for TAKHZYRO;
Attack reduction was consistently greater for patients taking TAKHZYRO vs placebo regardless of previous prophylaxis use, history of laryngeal attacks, or attack rate during run-in period.1
Secondary endpoints: significant reductions with TAKHZYRO every 2 weeks vs placebo in mean monthly rates of moderate or severe attacks from Day 0 to Day 182 (83%) and attacks requiring acute treatment from Day 0 to Day 182 (87%) (Adjusted P<0.001 vs placebo for all; n=27 for TAKHZYRO, n=41 for placebo)1§
‡Mean monthly attack rate: number of attacks/4 weeks.1
§Adjusted P-values for multiple testing.
SELECT IMPORTANT SAFETY INFORMATION
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.
MANY PATIENTS HAD ZERO ATTACKS
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 treatment4¶
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)4
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).1,4¶
¶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.4
-
Clinical trial 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).1,4
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.
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 wholly-owned, indirect subsidiary of Shire plc) at 1–800–828–2088, or FDA at 1–800–FDA–1088 or www.fda.gov/medwatch.
Please see full Prescribing Information here.
References: 1. TAKHZYRO (lanadelumab-flyo) [prescribing information]. Lexington, MA: Shire LLC; 2018. 2. CINRYZE (C1 esterase inhibitor [human]) [prescribing information]. Lexington, MA: Shire ViroPharma Incorporated; 2010. 3. HAEGARDA [prescribing information]. Kankakee, IL: CSL Behring LLC; 2017. 4. Data on file, SHP643-066, Shire Inc.