ORLADEYO can help to prevent HAE attacks1

ORLADEYO offers significant hereditary angioedema (HAE) attack rate reduction1

ORLADEYO demonstrated a significant attack rate reduction (44%) vs placebo (P<0.001).1,a

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

 

ORLADEYO consistently showed greater attack rate reductions vs placebo across response thresholds2

Relative HAE attack rate reduction with ORLADEYO™ Relative HAE attack rate reduction with ORLADEYO™

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
bExploratory endpoint; nominal P=0.005.1,3
cAd hoc analysis; nominal P=0.002.1,3
dAd hoc analysis; nominal P=0.073.1,3

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 reduced the need for rescue therapy2,3

In an ad hoc analysis, patients treated with ORLADEYO experienced a 54% reduction in rescue medication use per 28 days vs placebo (nominal P<0.001).2,3

ORLADEYO provides sustained HAE attack rate reduction3

Patients who completed 48 weeks of treatment saw sustained reductions in their HAE attack rates, demonstrating the durability of ORLADEYO.3

Reduction in APeX-2 mean attack rates over 48 weeks of treatment with ORLADEYO™ Reduction in APeX-2 mean attack rates over 48 weeks of treatment with ORLADEYO™

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

Thirty-one patients who were randomized to ORLADEYO 150 mg at the beginning of APeX-2 and completed 48 weeks of treatment demonstrated a decline in mean attack rate per 4 weeks from baseline to 48 weeks of treatment3:

Every individual with HAE responds differently to treatment. The clinical phenotype is variable and does not predict response to prophylactic therapy.4,5

Long-term effectiveness data from APeX-S are consistent with durability data from APeX-23

ORLADEYO was studied in an open-label, nonrandomized, long-term safety study3

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

APeX-S objectives

  • Primary objective: long-term safety and tolerability of daily dosing of ORLADEYO3
  • Secondary objective: effectiveness of ORLADEYO during long-term administration3

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

In 5 of the last 6 months of treatment, more than half of patients had 0 attacks.3,a

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