Results in Episodic Migraine | VYEPTI® (eptinezumab-jjmr)

PRIMARY
ENDPOINT

Primary endpoint

After a single dose of VYEPTI 100 mg, patients had 12 fewer migraine days, on average, over 3 months¹*

Episodic migraine—Primary endpoint: Mean change from baseline in mean MMD (Months 1-3)¹

Graph showing that, after the first dose, VYEPTI 100 mg and 300 mg dosages reduced the number of mean MMD by 3.9 and 4.3 (Months 1-3), respectively, vs 3.2 with placebo (baseline ~8.6 mean MMD; p=0.018 vs placebo for VYEPTI 100 mg; p<0.001 vs placebo for VYEPTI 300 mg).

*Calculated by multiplying the mean change from baseline in mean MMD by 3 months.¹

†p=0.018 vs placebo.¹

‡Analysis of covariance model used to test for difference between treatment groups.³

§p<0.001 vs placebo.¹

MMD, monthly migraine days.

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

POWERFUL: ≥50%
RESPONSE

POWERFUL: ≥50% RESPONSE: MONTHS 1-6

POWERFUL

≥50% response: Months 1-3

~50% of patients on VYEPTI experienced at least 50% fewer migraine days during Months 1-3¹*^†

Episodic migraine—≥50% migraine responder rate (Months 1-3)¹

Graph showing that 49.8% of patients on VYEPTI 100 mg experienced at least 50% fewer migraine days during Months 1-3 vs 37.4% with placebo.

50% responder rate was defined as a subject achieving ≥50% reduction from baseline in migraine days for each month within the 3-month interval.²

*One month was defined as 28 consecutive days.²

†p=0.009 vs placebo (nominal statistical significance).¹

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

POWERFUL: ≥50% RESPONSE: MONTHS 1-3

POWERFUL

≥50% response: Months 1-6

During the first 6 months of treatment, more than half of patients experienced at least 50% fewer migraine days⁴*

Episodic migraine—≥50% migraine responder rate^2,4

Graph showing that the ≥50% migraine responder rate was 59.3% for patients treated with VYEPTI 100 mg during Month 1 vs 40.5% with placebo, 49.8% for patients treated with VYEPTI 100 mg during Months 1-3 vs 37.4% with placebo, and 62.0% for patients treated with VYEPTI 100 mg during Months 4-6 vs 51.4% with placebo.

50% responder rate was defined as a subject achieving ≥50% reduction from baseline in migraine days for each month within the 3-month interval.²

*One month was defined as 28 consecutive days.²

†These are prespecified secondary endpoints, not adjusted for multiplicity.⁴

‡p=0.009 vs placebo (nominal statistical significance).³

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

Powerful: ≥75%
response

POWERFUL: ≥75% RESPONSE: MONTHS 1-6

POWERFUL

≥75% response: Months 1-3

Over 20% of patients on VYEPTI experienced at least 75% fewer migraine days during Months 1-3¹*

Episodic migraine—≥75% migraine responder rate (Months 1-3)¹

Graph showing that 22.2% of patients on VYEPTI 100 mg experienced at least 75% fewer migraine days during Months 1-3 vs 16.2% with placebo.

75% responder rate was defined as a subject achieving ≥75% reduction from baseline in migraine days for each month within the 3-month interval.²

*One month was defined as 28 consecutive days.²

†Not statistically significant.¹

VYEPTI was also studied in patients with chronic migraine

SEE THE RESULTS

POWERFUL: ≥75% RESPONSE: MONTHS 1-3

POWERFUL

≥75% response: Months 1-6

After the second dose, over 1 in 3 patients experienced at least 75% fewer migraine days⁵*

Episodic migraine—≥75% migraine responder rate²

Graph showing that 22.2% of patients on VYEPTI 100 mg experienced at least 75% fewer migraine days during Months 1-3 vs 16.2% with placebo, and 33.5% of patients on VYEPTI experienced at least 75% fewer migraine days during Months 4-6 vs 24.8% with placebo.

75% responder rate was defined as a subject achieving ≥75% reduction from baseline in migraine days for each month within the 3-month interval.²

*One month was defined as 28 consecutive days.²

†Not statistically significant.¹

‡This is a prespecified secondary endpoint, not adjusted for multiplicity.⁴

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

Powerful: ≥75%
response (Month 1)

POWERFUL

≥75% response: Month 1

Over 30% of patients experienced at least 75% fewer migraine days after one month³*

Episodic migraine—≥75% migraine responder rate (Month 1)³

Graph showing that the ≥75% migraine responder rate at Month 1 was 30.8% for patients treated with VYEPTI 100 mg vs 20.3% with placebo.

*One month was defined as 28 consecutive days.²

†p=0.011 vs placebo; stratified Cochran-Mantel-Haenszel test used for statistical analysis.³

75% migraine responder rate at Month 1 was a key secondary endpoint.³

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

Powerful: 100%
response

POWERFUL: 100% RESPONSE: MONTHS 1-6

POWERFUL

Migraine-free for a month or more

Nearly two-thirds of patients were migraine-free for a month or more with VYEPTI^2,6*^†

Episodic migraine—100% migraine responder rate^4,6

Graphic showing that during the 12-month study period, 63% of patients on VYEPTI 100 mg were migraine-free for a month or more vs 48% with placebo.

100% responder rate was defined as the percentage of subjects with migraine freedom for any 1 month during the respective dose internal.²

*One month was defined as 28 consecutive days.²

†Post hoc analysis, no determination of statistical significance can be made, and no conclusions should be drawn.^2,6

‡VYEPTI 100 mg: n=221; placebo: n=222.¹

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

POWERFUL: Migraine-free for a month or more

POWERFUL

100% response: Months 1-6

~20% of patients were migraine-free for a month or more following the second dose^2,6*

Episodic migraine—≥100% migraine responder rate^2,6

Graph showing that the 100% migraine responder rate was 8.6% for patients treated with VYEPTI 100 mg during Month 1 vs 5.9% with placebo, 11.4% for patients treated with VYEPTI 100 mg during Months 1-3 vs 9.1% with placebo, and 19.7% for patients treated with VYEPTI 100 mg during Months 4-6 vs 14.3% with placebo.

100% responder rate was defined as the percentage of subjects with migraine freedom for any 1 month during the respective dose internal.²

*One month was defined as 28 consecutive days.²

†These are prespecified secondary endpoints, not adjusted for multiplicity.²

‡Post hoc analysis, no determination of statistical significance can be made, and no conclusions should be drawn.^2,6

§Calculated by averaging the subjects’ 100% responder status.²

VYEPTI was also studied in patients with chronic migraine

SEE THE RESULTS

FAST: BENEFIT
AS SOON AS DAY 1

FAST: DAY 1 REDUCTION

FAST

Early benefit

VYEPTI: Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion¹*

Episodic migraine—Percentage of patients with a migraine from Day –1 (day prior to infusion) to Day 7¹

Graph showing that fewer patients treated with VYEPTI 100 mg experienced a migraine during the first 7 days of treatment compared to placebo.

*Data represent mean percent of patients based on observed data.¹

SE, standard error.

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

FAST: EARLY BENEFIT

FAST

Day 1 reduction

Day 1: >50% reduction in the percentage of patients experiencing a migraine^2,3

Episodic migraine—Migraine incidence was reduced by 52.3% on Day 1 vs 24.5% with placebo.^2,7*

Graph showing that migraine incidence was reduced by 52.3% on Day 1 for patients treated with VYEPTI 100 mg vs 24.5% with placebo.

*Over the 28-day screening period, the average baseline percentage of patients with a migraine any given day was ~30%.³ Day of infusion.²

†p=0.031 vs placebo, (nominal statistical significance), stratified Cochran-Mantel-Haenszel test used for statistical significance.³

‡Weeks 1-4: Post hoc analysis, no determination of statistical significance can be made, and no conclusions should be drawn.²

DAY 1

VYEPTI is the only preventive anti-CGRP to have demonstrated reduction in migraine incidence as soon as Day 1.³

CGRP, calcitonin gene-related peptide.

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

Sustained: Improvement
through Month 6

SUSTAINED

Improvement through Month 6

Reduced mean monthly migraine days by ~50% through Month 6 vs 28-42% with placebo^1,2*^†

Episodic migraine—Mean change from baseline in mean MMD^1,3

Graph showing that mean decreases from baseline in mean MMD were greater at every time point through Month 6 for patients treated with VYEPTI 100 mg vs placebo.

*This is a prespecified endpoint but not prespecified analyses.²

†Calculated from the percent change from baseline; percentages for VYEPTI range from 43-55%.²

MMD, monthly migraine days.

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

POWERFUL: EFFICACY SUMMARY

Powerful results for patients with episodic and chronic migraine*

Episodic Results

4 to 14 headache days per month, of which ≥4 were migraine days.^1†

Over 20% of patients experienced at least 75% fewer migraine days during Months 1-3 (22.2% vs 16.2% with placebo, not significant)1†

Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion1‡

Reduced mean monthly migraine days by ~50% through Month 6 (vs 28-42% with placebo)^1,2§¶

*Data from VYEPTI 100 mg dose groups.¹

†One month was defined as 28 consecutive days.²

‡Data represent mean percent of patients based on observed data.¹

§This is a prespecified endpoint but not prespecified analyses.²

¶Calculated from the percent change from baseline; percentages for VYEPTI range from 43-55%.²

Chronic Results

≥15 to ≤26 headache days per month, of which ≥8 were migraine days.^1†

~27% of patients on VYEPTI experienced at least 75% fewer migraine days during Months 1-3 (26.7% vs 15% with placebo, p<0.001)1†

Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion1‡

Reduced mean monthly migraine days by ~50% through Month 6 (vs 30-39% with placebo)^1,2§¶

*Data from VYEPTI 100 mg dose groups.¹

†One month was defined as 28 consecutive days.⁸

‡Data represent mean percent of patients based on observed data.¹

§This is a prespecified endpoint but not prespecified analyses.¹

¶Calculated from the percent change from baseline; percentages for VYEPTI range from 47-54%.²

VYEPTI was also studied in patients with chronic migraine.

SEE THE RESULTS

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EPISODIC MIGRAINE RESULTS

Explore the results:

Primary endpoint

After a single dose of VYEPTI 100 mg, patients had 12 fewer migraine days, on average, over 3 months1*

Episodic migraine—Primary endpoint: Mean change from baseline in mean MMD (Months 1-3)1

VYEPTI was also studied in patients with chronic migraine.

POWERFUL

≥50% response: Months 1-3

~50% of patients on VYEPTI experienced at least 50% fewer migraine days during Months 1-31*†

Episodic migraine—≥50% migraine responder rate (Months 1-3)1

VYEPTI was also studied in patients with chronic migraine.

POWERFUL

≥50% response: Months 1-6

During the first 6 months of treatment, more than half of patients experienced at least 50% fewer migraine days4*

Episodic migraine—≥50% migraine responder rate2,4

VYEPTI was also studied in patients with chronic migraine.

POWERFUL

≥75% response: Months 1-3

Over 20% of patients on VYEPTI experienced at least 75% fewer migraine days during Months 1-31*

Episodic migraine—≥75% migraine responder rate (Months 1-3)1

VYEPTI was also studied in patients with chronic migraine

POWERFUL

≥75% response: Months 1-6

After the second dose, over 1 in 3 patients experienced at least 75% fewer migraine days5*

Episodic migraine—≥75% migraine responder rate2

VYEPTI was also studied in patients with chronic migraine.

POWERFUL

≥75% response: Month 1

Over 30% of patients experienced at least 75% fewer migraine days after one month3*

Episodic migraine—≥75% migraine responder rate (Month 1)3

75% migraine responder rate at Month 1 was a key secondary endpoint.3

VYEPTI was also studied in patients with chronic migraine.

POWERFUL

Migraine-free for a month or more

Nearly two-thirds of patients were migraine-free for a month or more with VYEPTI2,6*†

Episodic migraine—100% migraine responder rate4,6

VYEPTI was also studied in patients with chronic migraine.

POWERFUL

100% response: Months 1-6

~20% of patients were migraine-free for a month or more following the second dose2,6*

Episodic migraine—≥100% migraine responder rate2,6

VYEPTI was also studied in patients with chronic migraine

FAST

Early benefit

VYEPTI: Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion1*

Episodic migraine—Percentage of patients with a migraine from Day –1 (day prior to infusion) to Day 71

VYEPTI was also studied in patients with chronic migraine.

FAST

Day 1 reduction

Day 1: >50% reduction in the percentage of patients experiencing a migraine2,3

Episodic migraine—Migraine incidence was reduced by 52.3% on Day 1 vs 24.5% with placebo.2,7*

DAY 1

VYEPTI is the only preventive anti-CGRP to have demonstrated reduction in migraine incidence as soon as Day 1.3

VYEPTI was also studied in patients with chronic migraine.

SUSTAINED

Improvement through Month 6

Reduced mean monthly migraine days by ~50% through Month 6 vs 28-42% with placebo1,2*†

Episodic migraine—Mean change from baseline in mean MMD1,3

VYEPTI was also studied in patients with chronic migraine.

Powerful results for patients with episodic and chronic migraine*

Episodic Results

Chronic Results

VYEPTI was also studied in patients with chronic migraine.

VYEPTI CONNECT: Your direct link to access support

VYEPTI is one 30-minute IV infusion every 3 months1

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IMPORTANT SAFETY INFORMATION

AND INDICATION

Contraindications

INDICATION

Warnings and Precautions

Adverse Reactions

IMPORTANT SAFETY INFORMATION

AND INDICATION

Contraindications

INDICATION

After a single dose of VYEPTI 100 mg, patients had 12 fewer migraine days, on average, over 3 months¹*

Episodic migraine—Primary endpoint: Mean change from baseline in mean MMD (Months 1-3)¹

~50% of patients on VYEPTI experienced at least 50% fewer migraine days during Months 1-3¹*^†

Episodic migraine—≥50% migraine responder rate (Months 1-3)¹

During the first 6 months of treatment, more than half of patients experienced at least 50% fewer migraine days⁴*

Episodic migraine—≥50% migraine responder rate^2,4

Over 20% of patients on VYEPTI experienced at least 75% fewer migraine days during Months 1-3¹*

Episodic migraine—≥75% migraine responder rate (Months 1-3)¹

After the second dose, over 1 in 3 patients experienced at least 75% fewer migraine days⁵*

Episodic migraine—≥75% migraine responder rate²

Over 30% of patients experienced at least 75% fewer migraine days after one month³*

Episodic migraine—≥75% migraine responder rate (Month 1)³

75% migraine responder rate at Month 1 was a key secondary endpoint.³

Nearly two-thirds of patients were migraine-free for a month or more with VYEPTI^2,6*^†

Episodic migraine—100% migraine responder rate^4,6

~20% of patients were migraine-free for a month or more following the second dose^2,6*

Episodic migraine—≥100% migraine responder rate^2,6

VYEPTI: Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion¹*

Episodic migraine—Percentage of patients with a migraine from Day –1 (day prior to infusion) to Day 7¹

Day 1: >50% reduction in the percentage of patients experiencing a migraine^2,3

Episodic migraine—Migraine incidence was reduced by 52.3% on Day 1 vs 24.5% with placebo.^2,7*

VYEPTI is the only preventive anti-CGRP to have demonstrated reduction in migraine incidence as soon as Day 1.³

Reduced mean monthly migraine days by ~50% through Month 6 vs 28-42% with placebo^1,2*^†

Episodic migraine—Mean change from baseline in mean MMD^1,3

VYEPTI is one
30-minute IV infusion every 3 months¹