Consistent safety

HELP STUDY

ADULT & ADOLESCENT (≥12)

HELP safety results

Safety profile established in the largest pivotal trial prevention study in HAE^1,3–5

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Most common ARs (≥10%) observed in the pivotal trial1,6*	TAKHZYRO every 2 weeks (n=27)	TAKHZYRO every 4 weeks (n=29)	Placebo (n=41)
Injection site reactions† Pain Erythema Bruising	56% 52% 7% 4%	45% 31% 7% 7%	34% 29% 2% 0%
Upper respiratory infection‡	44%	31%	32%
Headache§	33%	21%	22%
RashII	4%	10%	5%
Dizziness	4%	10%	0%
Diarrhea	4%	0%	5%
Myalgia	11%	0%	0%

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*≥10% in any TAKHZYRO group that also occurred at a higher rate than placebo group.¹

^†Additional injection site reactions included hematoma, hemorrhage, pruritus, swelling, induration, paresthesia reaction, warmth, edema, and rash.¹

^‡Includes upper respiratory infection, viral upper respiratory infection.¹

^§Includes headache, tension headache, sinus headache.¹

^IIIncludes rash, rash maculopapular, rash erythematous.¹

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Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.¹

No incidence of anaphylaxis in the pivotal trial.¹

Injection site reactions were the most common adverse reactions (ARs).¹

HELP ole study

ADULT & ADOLESCENT (≥12)

Consistent safety profile seen in 212 patients in the open-label extension study¹

Safety data of patients taking TAKHZYRO for an average of 30 months²

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Most common ARs (≥10%) observed in the HELP open-label study2	TAKHZYRO 300 mg every 2 weeks (N=212)
Injection site pain	47%
Viral upper respiratory tract infection	42%
Upper respiratory tract infection	26%
Headache	25%
Injection site erythema	17%
Arthralgia	13%
Injection site bruising	12%
Back pain	12%
Diarrhea	11%
Sinusitis	11%
Influenza	10%
Nausea	10%
Urinary tract infection	10%

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Mean study duration: 29.6 (SD=8.2) months.²

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Hypersensitivity reactions (2%, n=4) were reported in the study.^2*
Six patients discontinued due to treatment-emergent adverse events.²

• Three of the subjects discontinued due to hypersensitivity reactions²
• One hypersensitivity event was considered related to the study drug and led to discontinuation²
• No discontinuations due to injection site reactions, and most injection site reactions resolved within 1 hour (70.2%) or 1 day (92.6%)²
• No treatment-related serious adverse events or anaphylaxis were observed²

*Related, treatment-emergent hypersensitivity reactions.²

spring study

PEDIATRIC (2 TO <12)

Safety profile seen in patients as young as 2 years of age¹

Safety data of 21 pediatric patients taking TAKHZYRO for 52 weeks¹

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Most common related TEAEs7*	TAKHZYRO 150 mg every 2 or 4 weeks (N=21)
Injection site pain	29%
Injection site erythema	14%
Injection site swelling	5%
Administration site pain	5%
Injection site reaction	5%

The profile of related TEAEs was similar between the every-2-weeks and every-4-weeks dosing treatment groups.⁷

No deaths, serious TEAEs, hospitalizations, or discontinuations due to TEAEs were observed.⁷

No new safety signals were observed in these patients. Overall, the safety was similar between adult patients and pediatric patients (2 to <18 years of age).¹

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*Treatment-related TEAEs were TEAEs classified as related to lanadelumab treatment by the investigator.⁷
TEAE=treatment-emergent adverse event.