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INTRODUCING TAKHZYRO® ▼ (lanadelumab)

TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.1

The recommended starting dose is TAKHZYRO 300 mg every 2 weeks. In patients who are stably attack free on treatment, a dose reduction of TAKHZYRO 300 mg every 4 weeks may be considered, especially in patients with low weight.1

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the Summary of Product Characteristics for how to report adverse reactions.

Please see full EU Product Information.

The information on this website is intended for an international healthcare professional audience outside of the United States, United Kingdom, and Ireland only.

Unparalleled experience, with the longest active treatment duration across 2 studies1,8-12

HELP STUDY

Double blind, placebo controlled1

6.5 months

of active treatment

(1 month was defined as 28 days
throughout the clinical program)1,15

125 patients

with HAE Type I or II aged 12 years and older1

  • 56% of patients were previously treated with long-term preventive therapy1*
  • 52% of patients had ≥3 attacks per month during the run-in period (48% had 1 to 2 attacks)1,15

HELP OLE

Open-label, long term8

2.5 years

Average treatment
duration was ~30 months8

212 patients

with HAE Type I or II aged 12 years and older8

  • 59% of patients were previously treated with long-term preventive therapy8*
  • 39% of patients had ≥3 attacks per month at baseline (12% had <1 attack))8‡

*Including C1-INH alone, oral treatment (androgens or antifibrinolytics) alone, or both C1-INH and oral treatment.8,15

†Patients who had 1 to 2 attacks during the run-in period is a calculation (n=60/125).15

‡In HELP OLE, nonrollover patients were required to have a historical attack rate of at least 1 attack within 12 weeks.8

C1-INH=C1 esterase inhibitor; HELP=Hereditary angioEdema Long-term Prophylaxis; OLE=open-label extension.

The HELP Clinical Program

The HELP Clinical Program
  • Mean monthly reduction in attacks with TAKHZYRO vs placebo was the primary endpoint in the HELP study1
  • Long-term safety of repeated dosing of TAKHZYRO was the primary endpoint in the HELP OLE8

The recommended starting dose is 300 mg every 2 weeks. In patients who are stably attack free on treatment, a dose reduction of 300 mg every 4 weeks may be considered, especially in patients with low weight.1

*LTP washout period was only for patients ≥18 years of age.16

†Run-in period could be shortened if patients experienced ≥3 attacks before completion of 4 weeks. If patients experienced no attacks within 4 weeks, the run-in period was extended for another 4 weeks, during which time they needed to have ≥2 attacks to proceed to enrolment and randomisation.24

‡Treatments were administered as 2 separate 1-mL injections in the upper arm every 2 weeks to maintain blinding.15

§The 4-week screening period of the HELP OLE did not include an LTP washout period.23

For rollover patients, Day 0 of the HELP OLE coincided with Day 182 (Week 26) of the HELP study. For nonrollover patients, the first dose was administered on Day 0.8

#Regardless of when the first HAE attack occurred, there was a minimum of 10 days between the first and second open-label doses.25

HAE=hereditary angioedema; HELP=Hereditary angioEdema Long-term Prophylaxis; OLE=open-label extension.

Favourable long-term safety and tolerability profile

<1.4%

OF PATIENTS DISCONTINUED

due to adverse reactions over 3 years of treatment across 2 studies8,15,17
HELP STUDY

One patient discontinued due to an adverse event15

  • Across 3 TAKHZYRO treatment arms that included 84 patients, 1 patient (~1.2% of patients) taking TAKHZYRO 300 mg every 4 weeks discontinued due to an adverse event15
HELP OLE

Three patients discontinued due to treatment-related adverse events8,17

  • Over 132 weeks of treatment, 3 out of 212 patients taking TAKHZYRO (~1.4% of patients) discontinued due to treatment-related adverse events (all hypersensitivity reactions)8,17

All results were with TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.

*HELP=Hereditary angioEdema Long-term Prophylaxis; OLE=open-label extension.

Clinically meaningful improvement in quality of life with TAKHZYRO (tertiary endpoint)13*

HELP study (6.5 months)
cmi chart

Patients taking TAKHZYRO were 7 times more likely to reach MCID than patients taking placebo based on an odds ratio.13

Clinically meaningful improvement is defined as a reduction of ≥6.1

A REDUCTION IN SCORE SHOWS IMPROVEMENT1

  • Mean change in total AE-QoL score: -21.3 with TAKHZYRO (n=26; P<0.05); -4.7 with placebo (n=38) (tertiary endpoint)13

All results were with TAKHZYRO 300 mg every 2 weeks.

*These findings are tertiary endpoint analyses and therefore require further investigation to corroborate.

AE-QoL=Angioedema Quality of Life Questionnaire; HELP=Hereditary angioEdema Long-term Prophylaxis; MCID=minimal clinically important difference.