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03.25.20

Pivotal Phase 3 Results Published for Eptinezumab, Recently FDA-Approved for Migraine Prevention in Adults 

  • KEYWORDS:
  • Eptinezumab
  • Headache
  • Migraine

Results of the phase 3 Promise 2 study (NCT02974153) published in Neurology demonstrated that use of eptinezumab (Vyepti, Lundbeck, Deerfield, IL) as a preventive treatment for chronic migraine in adults significantly reduced the mean number of migraine days/month (MMD) over months 1 to 3. Chronic migraine was defined as 15 to 26 headache days per month, of which at least 8 were migraine days. The migraine preventive effect of eptinezumab was statistically significant vs placebo as early as day 1 and maintained for 3 months postinfusion. Approximately one-third of individuals who took eptinezumab reduced the number of mean MMD by 75% or more at month 1. Individuals treated with eptinezumab were also more likely to achieve a 75% or greater response during months 1 to 3 compared with those treated with placebo (Table). The results are supportive of the findings from the Promise 1 study in adults with episodic migraine, which were published online in the journal Cephalalgia on February 19, 2020.

TABLE. Effects of Eptinezumab vs Placebo for Prevention of Chronic Migraine in Adults 

Eptinezumab 300 mg

Eptinezumab 100 mg

Placebo

Mean MMD decrease

8.2 days

7.7 days

5.6 days

% who had >75% reduction in 1 month

36.9%

30.9%

15.6%

% with migraine 1 day post injection

27.8%

28.6%

42.3%

Estimated mean change from baseline

-29.8%

-27.1%

-18.8%

 


Eptinezumab was recently approved by the Food and Drug Administration (FDA) for the preventive treatment of migraine in adults. The recommended dose is 100 mg every 3 months; some patients may benefit from a dose of 300 mg. Administered via a 30-minute intravenous (IV) infusion every 3 months, eptinezumab is the first and only IV treatment for migraine prevention.
 
“The Promise 2 study found that Vyepti is associated with a clinically meaningful migraine preventive effect over multiple efficacy measures and is well tolerated in adults with chronic migraine,” said study lead author Richard B. Lipton, MD, director, Montefiore Medical Center, professor of Neurology, Albert Einstein College of Medicine, NY. “The early onset of effect we saw with Vyepti in this study may translate into meaningful benefits for patients with chronic migraine and may allow them to get back to work, school, household, and family obligations sooner.” Dr. Lipton has consulted for and received research funding from Alder, a company acquired by Lundbeck.
Eptinezumab was well tolerated in the study with similar rates of treatment-emergent adverse events (TEAE) vs placebo. Overall, 47.4% of participants experienced at least 1 TEAE. The incidence of TEAEs was generally balanced among treatment groups: 43.5% for 100 mg, 52.0% for 300 mg, and 46.7% for placebo. Nasopharyngitis was the only TEAE reported for more than 2% of eptinezumab treated participants at an incidence of greater than 2% over placebo in this study; it occurred in the eptinezumab 300 mg study arm (eptinezumab: 9.4%, placebo: 6.0%).
 
“The publications of Promise 2 and Promise 1 in Neurology and Cephalalgia, respectively, underscore the scientific support of Vyepti as a powerful and generally well-tolerated preventive therapy with 4 infusions a year,” said Roger Cady, MD, head of Neurology Medical, Lundbeck Seattle Biopharmaceuticals. “These publications also further highlight the design of Vyepti as an IV infusion to deliver 100% of the medicine into the bloodstream by the end of the infusion.”
 

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