qulipta 12-WEEK EFFICACY

QUICK MIGRAINE
DAY
REDUCTION

Significant reductions across 12 weeks1

QULIPTA 60 mg

Primary endpoint: mean monthly migraine day (MMD) reduction across 12 weeks.
Baseline MMD was, on average, 7.7.1

54% migraine day reduction across 12 weeks
(4.2 fewer monthly migraine days from 7.8 baseline) vs 33% (2.5 fewer monthly migraine days from 7.5 baseline) with placebo1
QULIPTA 60 mg (n=222); placebo (n=214); P<0.001

Primary endpoint: Mean monthly migraine day (MMD) reduction across 12 weeks

WITH SIGNIFICANT REDUCTIONS AS EARLY AS3,4:

Additional endpoints

DAY 1

AFTER THE FIRST DOSE†‡

51%

LESS LIKELY TO HAVE A MIGRAINE ATTACK COMPARED WITH PLACEBO

Week 1

Significant reduction‡§

53%

Migraine day reductioN n=216

Placebo

15% n=211

The majority of impact occurred within Weeks 1-4.3

*Data from Phase 3 ADVANCE trial.

Day 1 data: 12.3% (n=211) of QULIPTA 60 mg patients had a migraine day vs 25.2% (n=202) of placebo patients.3

P≤0.0006.3

§Week 1 QULIPTA 60 mg: Baseline MMD was 1.93; change from baseline: -1.03. Week 1 placebo: Baseline MMD was 1.88; change from baseline: -0.29.3

Primary Endpoint:

> QULIPTA 30 mg: 3.9 fewer monthly migraine days across 12 weeks (baseline MMD was 7.9) (n=223) (P<0.001)1

> QULIPTA 10 mg: 3.7 fewer monthly migraine days across 12 weeks (baseline MMD was 7.7) (n=214) (P<0.001)1

Limitation
The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity.

CONTINUOUS MIGRAINE PREVENTIVE POWER

Reductions continued across 12 weeks1

On average, QULIPTA 60 mg patients saw a 53% reduction from baseline in migraine days compared to 15% with placebo during the first week of treatment. On average, QULIPTA 60 mg patients saw a 53% reduction from baseline in migraine days compared to 15% with placebo during the first week of treatment. On average, QULIPTA 60 mg patients saw a 53% reduction from baseline in migraine days compared to 15% with placebo during the first week of treatment.

BASELINE MMD WAS, ON AVERAGE, 7.7.1

  • QULIPTA 10 mg: -4.24 migraine days at Weeks 9-12 (n=188) (P=0.0002)3

Phase 2b/3 Dose-finding Study Results
Primary endpoints:
QULIPTA 60 mg: -3.6 monthly migraine days across 12 weeks (baseline MMD was 7.7) (n=177) (P=0.039).
QULIPTA 30 mg: -3.8 monthly migraine days across 12 weeks (baseline MMD was 7.6) (n=182) (P=0.039).
QULIPTA 10 mg: -4.0 monthly migraine days across 12 weeks (baseline MMD was 7.6) (n=92) (P=0.024).
Placebo: -2.8 monthly migraine days across 12 weeks (baseline MMD was 7.8) (n=178).1

POWERFUL PATIENT RESPONSE

Over 60% of patients cut
their migraine days by at
least half1*

MANY PATIENTS ACHIEVED A 50% TO 100% REDUCTION IN MONTHLY MIGRAINE DAYS WITH QULIPTA 60 mg1,3

≥50% Response rate

Secondary endpoint: Percentage of patients who achieved ≥50% MMD reduction across 12 weeks1,2

Additional endpoint: Percentage of patients who achieved ≥50% MMD reduction in Weeks 1-4, 5-8, 9-123,4

On average, 61% achieved a ≥ 50% migraine day reduction from baseline over 12 weeks on QULIPTA 60 mg

Similar percentages
were seen with other doses 1:

  • 59% for QULIPTA 30 mg (n=223) (P<0.001)
  • 56% for QULIPTA 10 mg (n=214) (P<0.001)

Limitation
The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity.

100% Response rate

Additional endpoint: Percentage of patients who achieved 100% MMD reduction.3,4

On average, 8% of patients achieved a 100% migraine day reduction over 12 weeks on QULIPTA 60 mg

Similar percentages
were seen with other doses3:

  • 5% for QULIPTA 30 mg (n=223) (P=0.0207)
  • 8% for QULIPTA 10 mg (n=214) (P=0.0036)

Limitation
The 100% response rate analysis was an additional endpoint not tested in hierarchical order or adjusted for multiplicity.

*Data from the Phase 3 ADVANCE trial.

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