ORLADEYO® (berotralstat) helps to prevent
hereditary angioedema (HAE) attacks1

ORLADEYO offers significant HAE attack rate reduction1

ORLADEYO demonstrated a significant attack rate reduction over 24 weeks from 3.06 to 1.31 attacks per month compared with a reduction of 2.91 to 2.35 attacks per month with placebo (44% reduction vs placebo, P<0.001).1,2,a

  •  The effect of ORLADEYO in reducing attacks was seen within the first 4 weeks and maintained over 24 weeks1

aThe percent reduction in attack rate was greater with ORLADEYO 150 mg relative to placebo regardless of attack rate during the run-in period.1

Attack Rate

ORLADEYO was studied in one of the largest clinical studies for a prophylactic therapy in hereditary angioedema (HAE)2

APeX-2 is a 3-part, double-blind, placebo-controlled study. The APeX-2 part 1 primary efficacy endpoint was HAE attack rate at 24 weeks.2,3

aPatients were allowed to use rescue medications to treat attacks but had to discontinue all prophylactic HAE medications prior to the start of the study.1
bIn part 2 of the study, patients on active drug in part 1 continued on the same dose and patients on placebo in part 1 were rerandomized to a blinded active dose.2

ORLADEYO was studied in patients like yours3

Patients in APeX-2 had a considerable disease history and burden.3

aBaseline investigator-confirmed attack rate was defined as (total number of investigator-confirmed HAE attacks experienced in the period between screening and first date/time of study drug) x 28/(date of first dose – date of screening + 1).3
bBased on 120 subjects. One subject was randomized but did not receive study drug. As this subject did not receive drug, the subject had no baseline calculations.3
cResponses for individual drugs may not be mutually exclusive. Percentages were based on the number of responses per category and may not sum to 100%.3
dIncludes plasma-derived C1-INH replacement, recombinant C1-INH replacement, and fresh frozen plasma.3
eIncludes unspecified androgens, oxandrolone, methyl-testosterone, danazol, and stanozolol.3

ORLADEYO provides sustained HAE attack rate reduction4

Patients who completed 96 weeks of treatment saw sustained reductions in their HAE attack rates, demonstrating the durability of ORLADEYO.4

  • Twenty-one patients who were randomized to ORLADEYO 150 mg at the beginning of APeX-2 and completed 96 weeks of treatment demonstrated a decline in mean attack rate per 4 weeks from baseline to 96 weeks of treatment4,b

In 16 of the last 17 months of treatment,
median attack rate was 0 attacks per month
4,b

 

 
Abbreviation: SEM, standard error of the mean.
bThis reflects an ad hoc analysis of interim data.3
c86% attack rate reduction from baseline to week 96 was seen for patients who completed 96 weeks of treatment with ORLADEYO 150 mg (n=21).4
dDue to study design, investigator-confirmed attack rates were reported only during the first 48 weeks, while patient-reported attack rates were reported during weeks 49 to 96. For consistency across the entire 96 weeks, only patient-reported attack rates are reported. For analysis purposes, 1 month was defined as 4 weeks of treatment.4

ORLADEYO reduced the need for rescue therapy3

In an ad hoc analysis of the first 24 weeks of treatment, patients treated with ORLADEYO 150 mg experienced a reduction in rescue medication use per 28 days vs placebo (nominal P<0.001).3

Every individual with HAE responds differently to treatment. The clinical
phenotype is variable and does not predict response to prophylactic therapy.
See if ORLADEYO could be right for your patients.5,6

Long-term effectiveness data from APeX-S are consistent with durability data from APeX-27

ORLADEYO was studied in an open-label, nonrandomized, long-term safety study7

With the addition of APeX-S, ORLADEYO has been studied in one of the largest clinical study programs for HAE.3,4

APeX-S objectives

  • Primary objective: long-term safety and tolerability of daily dosing of ORLADEYO7
  • Secondary objective: effectiveness of ORLADEYO during long-term administration7

The first 73 patients in the ORLADEYO 150 mg group to complete 48 weeks of treatment experienced a mean attack rate per 4 weeks of3,7

 

In 5 of the last 6 months of treatment,
median attack rate was 0 attacks per month
7,a

 

aIn an ad hoc analysis of those who had completed 48 weeks of the ongoing study.3

With the addition of APeX-S, ORLADEYO has been studied in one of the largest clinical study programs for HAE.2,3