Vyepti For Migraine Prevention. 2023
Migraine is a genetic, neurologic problem affecting 12 % of the world’s population. 25% of women and 6 % of men have migraine and for women Migraine is the most frequent medical problem, occurring more often than hypertension, diabetes, or arthritis.
A quick responding, high dose CGRP treatment for Migraine prevention is needed.
This is an article by Britt Talley Daniel MD, member of the American Academy of Neurology, the American Headache Society, migraine textbook author, podcaster, YouTube video producer, and blogger.
The FDA has approved Vyepti (Eptinezumab) as treatment for Migraine prevention. Vyepti (Eptinezumab) is a monoclonal antibody inhibitor of calcitonin gene-related peptide (CGRP). It is delivered by intravenous infusion and has an earlier onset of treatment effect than the other 3 subcutaneously delivered CGRP drugs available for Migraine prevention.
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Dosing
The recommended dose for migraine headache prophylaxis is 100 mg IV every 3 months although some individuals may benefit from a higher dose of 300 mg IV every 3 months. Dosing for hepatic or renal impairment is not defined. Pediatric dosing is not available or applicable for this drug.
There are no Black Box warnings.
Onset of activity
In patients with chronic migraine eptinezumab 100 and 300 mg was associated with a significant reduction in Migraine days from the day after IV administration through week 12. Eptinezumab was well tolerated, and demonstrated an acceptable safety profile.
Vyepti showed treatment benefit in the first 7 days, and sometimes even as quickly as 1 day post treatment which lasted through the entire 4 week dose time. Other once monthly subcutaneously injected CGRP antibodies often have a wearing off of treatment effect at the end of the 4 week treatment cycle. This likely relates to the usual higher medication dose delivered by IV infusion in comparison with Subcutaneous drug administration.
Contraindications/cautions
Hypersensitivity to CGRP drug or class of drugs.
Adverse reactions
Participants in the clinical trial who received at least 1 dose of eptinezumab had a low rate of adverse events, which most commonly were nasopharyngitis and hypersensitivity.
Only 1.9% of enrolled participants discontinued treatment because of adverse events.
Serious reactions-Hypersensitivity reaction
Common reactions
Nasopharyngitis
Hypersensitivity reaction
Angioedema’
Urticaria
Facial flushing
Rash
Drug interactions
None
Safety/monitoring
No routine tests recommended
Pregnancy/Lactation
Caution advised during pregnancy or while breastfeeding. There is no human data available.
Pharmacology
Metabolism is through proteolytic degradation. There is no interaction with CP450.
Excretion is unknown. The half-life is 27 days.
Mechanism of action is blocking of calcitonin gene-related peptide (CGRP). It is a monoclonal antibody.
FDA approval
This was based upon data from the PROMISE-1 clinical trial of eptinezumab for episodic migraine and the PROMISE-2 clinical trial for chronic migraine.
Treatment benefit was observed for both doses of eptinezumab as early as day 1 after infusion and treatment benefits were sustained over a 6-month period with 2 quarterly doses.
Table below
Mean Reduction in Monthly Migraine Days with Eptinezumab
Over 1 to 3 Months
Mean baseline frequency 300 mg quarterly 100 mg quarterly Placebo
8.6 MMD -4.3 MMD -3.9 MMD -3.2
Episodic Migraine (P<.001) (P<.018)
——————————————————————————————————————-
16.1 MMD -8.2 MDD -7.7 MMD -5.6
Chronic Migraine (P<.001) (P<.001)
MMD=monthly migraine days
In months 1 through 3, 56.3% and 49.8% of those with episodic migraine who were treated with 300 mg or 100 mg of eptinezumab respectively achieved at least a 50% reduction in migraine days per month (MMD) vs 37.4% of those treated with placebo (nominal P=.009).
For those with chronic migraine treated with 300 mg or 100 mg of eptinezumab 300 or 100 mg, 61.4% (P<.001) and 57.6% (P<.001) vs 39.3% of those who received placebo had at least a 50% reduction in MMD.
About Migraine
Migraine is one of the most painful conditions in the world and affects 1 billion people. The painful conditions are childbirth, a kidney stone, and migraine headache.
Migraine is also one of the most disabling of medical problems. The International Classification of Headache Disorders 3 defines chronic migraine as 15 or more headache days a month, 8 of which have migraine features of being one-sided, moderate or severe, throbbing, and associated with sensitivity to light and noise and nausea and vomiting. Episodic migraine is less than 15 headache days per month.
The Migraine process releases 3 inflammatory neurochemicals: Neurokinin A, Substance P, and CGRP.
CGRP is the most important of the neurochemicals and drugs modulating its effect are now used for acute and chronic Migraine prevention.
Comments by Headache experts
“The data showed that many patients with chronic migraine can achieve reduction in migraine days of at least 75 percent and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Dr. Peter Goadsby, a professor of neurology at King’s College, London and the University of California, San Francisco. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”
Dr. Deborah Dunsire, president and chief executive officer of Lundbeck, commented “With the approval of Vyepti, I am pleased that we are now able to offer a new intravenous therapy that achieves the key treatment goal of preventing migraine over time while also delivering on the need for earlier onset of efficacy. The Vyepti clinical program is the first to demonstrate this early benefit.”
This medication being given IV will have to administered in out-patient IV infusion units or in a doctor’s office making it different from the ease of personal subcutaneous administration of the other 3 CGRP drugs available—Ajovy, Aimovig, and Emgality.
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All the best.
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Britt Talley Daniel MD