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FDA has approved Vyepti, the first intravenous preventive treatment for migraine


Vyepti ( Eptinezumab-jjmr; Eptinezumab ) has been approved by the U.S. Food and Drug Administration ( FDA ) for the preventive treatment of migraine.
The recommended dose is 100 mg every 3 months; some patients may benefit from a dose of 300 mg.
Vyepti is the first FDA-approved intravenous ( IV ) treatment for migraine prevention.

The efficacy and safety of Vyepti was demonstrated in two phase III clinical trials ( PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine ).
The clinical trial program has demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for Vyepti than with placebo for most of the first 7 days.
The safety of Vyepti was evaluated in 2,076 patients with migraine who received at least one dose of Vyepti.
The most common adverse reactions ( 2% or more and at least 2% or greater than placebo ) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.
In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti has discontinued treatment due to adverse reactions.

The PROMISE-2 data have shown that many patients can achieve reduction in migraine days of at least 75% and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients.

Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide ( CGRP ) ligand and blocks its binding to the receptor.

Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound.
It is estimated to affect approximately 39 million people in the U.S. and more than 1.3 billion worldwide, and impacts three times as many women than men.
It is the second leading cause of years lived with disability ( YLD ) among all diseases, and is the top YLD cause among patients aged 15 to 49 years, according to the Global Burden of Disease study.
Migraine has a profound impact on patients’ lives, their relationships, as well as their ability to carry out activities of daily living. More than 157 million work days are lost each year in the U.S. due to migraine.

PROMISE Clinical Trial Program

The efficacy of Eptinezumab was evaluated as a preventive treatment of episodic and chronic migraine in two randomized, placebo-controlled studies, both with 6-month double-blind periods: one study in episodic ( PROMISE-1; defined as 4-14 headache days per month, of which at least 4 were migraine days ) and one study in patients with chronic migraine ( PROMISE-2; defined as 15-26 headache days per month, of which at least 8 were migraine days ).
In both studies, patients were randomized to receive placebo, Eptinezumab 100 mg, or Eptinezumab 300 mg.
The primary endpoint was the change from baseline in mean monthly migraine days over months 1-3.
Patients were allowed to use concurrent acute migraine or headache medications, including migraine-specific medications ( i.e., triptans, Ergotamine derivatives ), during the trial.
Both studies excluded patients with a history of cardiovascular disease ( hypertension, ischemic heart disease ), neurological disease, and cerebrovascular disease.
In PROMISE-2, the study population included patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute-medication overuse of triptans, Ergotamine, or combination analgesics greater than 10 days per month.

PROMISE-1: A total of 665 patients were randomized to receive placebo ( n=222 ), 100 mg Eptinezumab ( n=221 ), or 300 mg Eptinezumab ( n=222 ) every 3 months for 12 months.
Mean migraine frequency at baseline was approximately 8.6 migraine days per month and was similar across treatment groups.
Mean change from baseline in monthly migraine days with Eptinezumab compared with placebo months 1-3: -3.9 days for 100 mg ( p=0.018 ), -4.3 days for 300 mg ( p less than 0.001 ), and -3.2 days for placebo.
Percent responders with at least 50% reduction in monthly migraine days in months 1-3 compared with placebo: 49.8% for 100 mg ( nominal statistical significance p=0.009 ), 56.3% for 300 mg ( p less than 0.001 ), and 37.4% for placebo.
Percent responders with at least 75% reduction in monthly migraine days in months 1-3: 22.2% for 100 mg ( p=NS [ not statistically significant ] ), 29.7% for 300 mg ( p less than 0.001 ), and 16.2% for placebo.
Greater percentage of placebo-treated patients had migraine on most days during the first 7 days of treatment compared to Eptinezumab-treated patients.

PROMISE-2: A total of 1,072 patients were randomized to receive placebo ( n=366 ), 100 mg Eptinezumab ( n=356 ), or 300 mg Eptinezumab ( n=350 ) every 3 months for 6 months.
Mean migraine frequency at baseline was approximately 16.1 migraine days per month and was similar across treatment groups.
Mean change from baseline in monthly migraine days compared with placebo months 1-3: -7.7 days for 100 mg ( p less than 0.001 ), -8.2 days for 300 mg ( p less than 0.001 ), and -5.6 days for placebo.
Percent responders with at least 50% reduction in monthly migraine days in months 1-3 compared with placebo: 57.6% for 100 mg ( p less than 0.001 ), 61.4% for 300 mg ( p less than 0.001 ), and 39.3% for placebo.
Percent responders with at least 75% reduction in monthly migraine days in months 1-3: 26.7% for 100 mg ( p less than 0.001 ), 33.1% for 300 mg ( p less than 0.001 ), and 15.0% for placebo.
Greater percentage of placebo-treated patients had migraine on each individual day during the first 7 days of treatment compared to Eptinezumab-treated patients. ( Xagena )

Source: Lundbeck, 2020

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