FDA News

FDA approves Vyepti, first IV preventive treatment for migraine

Roger Cady
Roger Cady

The FDA has recently approved Vyepti, the first IV calcitonin gene-related peptide blocker for migraine prevention in adults, according to a press release from the manufacturer.

Vyepti (eptinezumab-jjmr, Lundbeck) offers the 39 million Americans who experience migraine “unique benefits” that other FDA-approved CGRP blockers — Aimovig, Ajovy and Emgality — do not, Roger Cady, MD, vice president of neurology at Lundbeck, told Healio Primary Care.

“First, no other approved preventive CGRP therapy has clinical data in their label showing effect before 30 days and in some cases 3 months or longer,” he said. “Second, eptinezumab-jjmr was developed for administration by IV infusion to deliver 100% of the medication quickly into the blood stream, so it can start to work as soon as possible after administration.”

Stuart Tepper
Stewart Tepper

In contrast, the previously approved CGRP blockers administered via subcutaneous injection take anywhere from 2 days to 1 week to take effect, Stewart J. Tepper, MD, a professor of neurology at Dartmouth Geisel School of Medicine who supervised some of the eptinezumab-jjmr’s trials, told Healio Primary Care.

Source:  Migraine Research Foundation

He added that within 24 hours of eptinezumab infusion, “more than half the patients were 50% less likely to experience migraine. That is such a fast onset and such a dramatic reduction, that [researchers] are studying eptinezumab for use in emergency rooms for the treatment of acute migraine.”

Healio Primary Care has previously reported on trials leading up to eptinezumab jjmr’s approval. This includes several phase 3 trials that concluded between 10% and 17% of patients who received the drug were migraine-free during any given month and the frequency of migraine-free months increased with ensuring quarterly infusions. The trials also showed that eptinezumab-jjmr recipients had better Headache Impact Test-6 (HIT-6) scores than placebo recipients. Adverse events tied to eptinezumab use include nasopharyngitis, upper respiratory infection, nausea, UTI, dizziness, arthralgia, anxiety and fatigue, according to the trial results.

Jessica Ailani
Jessica Ailani

With previous research indicating that the uptake of migraine treatment options is limited among primary care physicians, Jessica Ailani, MD, director of the MedStar Georgetown Headache Center in Washington, D.C., provided some tips to help patients and PCPs decide which migraine treatment option is best.

“All four CGRPs have good data for safety and efficacy. Therefore, consider eptinezumab for patients whose insurance covers it, who want quarterly in-office dosing and who are looking for day 1 improvement,” she told Healio Primary Care. “An example patient may be someone who is stuck in migraine status who has more than 4 migraine days monthly but has had daily migraine for more than a few days [and is] not responding to their at-home treatment.”

Healio Primary Care has also previously reported that 1-hour informational sessions with headache medicine specialists, clinical pharmacists and patients were an “effective and efficient way” to educate patients about the CGRP blockers for migraine prevention, according to researchers at the American Headache Society Annual Scientific Meeting. Topics covered at these sessions include each drug’s pathophysiology, potential benefits, risks for taking them during pregnancy, proper administration technique, insurance coverage, pharmacy plan benefits and cost.

Stephen Silberstein
Stephen D. Silberstein

Cady said that the price of eptinezumab-jjmr has not been set. However, Stephen D. Silberstein, MD, director of the Headache Center at Jefferson Health in Philadelphia, felt that the price would be less than $10,000 annually before any discounts are applied. Silberstein, who has also been involved in clinical trials evaluating eptinezumab-jjmr, said that is not an unreasonable price.

“The WHO has called migraine a major disorder that is associated with disability,” Silberstein told Healio Primary Care. “A patient with migraine is more disabled than someone who is paralyzed in their arms and legs.”

According to Cady, eptinezumab-jjmr will likely become available in April. – by Janel Miller

Disclosures: Ailani reports serving as a consultant for Allergan, Amgen, Biohaven, Eli Lilly, Impel, Lundbeck, Revancem Statsuma, Teva and Zosano; serving as speaker for Allergan, Amgen, Biohaven, Eli Lilly, Lundbeck and Teva; and receiving clinical trial support from Allergan, the American Migraine Foundation, Biogaven and Eli Lilly. Cady is employed by Lundbeck. Silverstein and Tepper report participating in clinical trials for eptinezumab-jjmr and other migraine treatments.

Roger Cady
Roger Cady

The FDA has recently approved Vyepti, the first IV calcitonin gene-related peptide blocker for migraine prevention in adults, according to a press release from the manufacturer.

Vyepti (eptinezumab-jjmr, Lundbeck) offers the 39 million Americans who experience migraine “unique benefits” that other FDA-approved CGRP blockers — Aimovig, Ajovy and Emgality — do not, Roger Cady, MD, vice president of neurology at Lundbeck, told Healio Primary Care.

“First, no other approved preventive CGRP therapy has clinical data in their label showing effect before 30 days and in some cases 3 months or longer,” he said. “Second, eptinezumab-jjmr was developed for administration by IV infusion to deliver 100% of the medication quickly into the blood stream, so it can start to work as soon as possible after administration.”

Stuart Tepper
Stewart Tepper

In contrast, the previously approved CGRP blockers administered via subcutaneous injection take anywhere from 2 days to 1 week to take effect, Stewart J. Tepper, MD, a professor of neurology at Dartmouth Geisel School of Medicine who supervised some of the eptinezumab-jjmr’s trials, told Healio Primary Care.

Source:  Migraine Research Foundation

He added that within 24 hours of eptinezumab infusion, “more than half the patients were 50% less likely to experience migraine. That is such a fast onset and such a dramatic reduction, that [researchers] are studying eptinezumab for use in emergency rooms for the treatment of acute migraine.”

Healio Primary Care has previously reported on trials leading up to eptinezumab jjmr’s approval. This includes several phase 3 trials that concluded between 10% and 17% of patients who received the drug were migraine-free during any given month and the frequency of migraine-free months increased with ensuring quarterly infusions. The trials also showed that eptinezumab-jjmr recipients had better Headache Impact Test-6 (HIT-6) scores than placebo recipients. Adverse events tied to eptinezumab use include nasopharyngitis, upper respiratory infection, nausea, UTI, dizziness, arthralgia, anxiety and fatigue, according to the trial results.

Jessica Ailani
Jessica Ailani

With previous research indicating that the uptake of migraine treatment options is limited among primary care physicians, Jessica Ailani, MD, director of the MedStar Georgetown Headache Center in Washington, D.C., provided some tips to help patients and PCPs decide which migraine treatment option is best.

“All four CGRPs have good data for safety and efficacy. Therefore, consider eptinezumab for patients whose insurance covers it, who want quarterly in-office dosing and who are looking for day 1 improvement,” she told Healio Primary Care. “An example patient may be someone who is stuck in migraine status who has more than 4 migraine days monthly but has had daily migraine for more than a few days [and is] not responding to their at-home treatment.”

Healio Primary Care has also previously reported that 1-hour informational sessions with headache medicine specialists, clinical pharmacists and patients were an “effective and efficient way” to educate patients about the CGRP blockers for migraine prevention, according to researchers at the American Headache Society Annual Scientific Meeting. Topics covered at these sessions include each drug’s pathophysiology, potential benefits, risks for taking them during pregnancy, proper administration technique, insurance coverage, pharmacy plan benefits and cost.

Stephen Silberstein
Stephen D. Silberstein

Cady said that the price of eptinezumab-jjmr has not been set. However, Stephen D. Silberstein, MD, director of the Headache Center at Jefferson Health in Philadelphia, felt that the price would be less than $10,000 annually before any discounts are applied. Silberstein, who has also been involved in clinical trials evaluating eptinezumab-jjmr, said that is not an unreasonable price.

“The WHO has called migraine a major disorder that is associated with disability,” Silberstein told Healio Primary Care. “A patient with migraine is more disabled than someone who is paralyzed in their arms and legs.”

According to Cady, eptinezumab-jjmr will likely become available in April. – by Janel Miller

Disclosures: Ailani reports serving as a consultant for Allergan, Amgen, Biohaven, Eli Lilly, Impel, Lundbeck, Revancem Statsuma, Teva and Zosano; serving as speaker for Allergan, Amgen, Biohaven, Eli Lilly, Lundbeck and Teva; and receiving clinical trial support from Allergan, the American Migraine Foundation, Biogaven and Eli Lilly. Cady is employed by Lundbeck. Silverstein and Tepper report participating in clinical trials for eptinezumab-jjmr and other migraine treatments.

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