FDA approved Vyepti (eptinezumab-jjmr) for Preventive Treatment of Migraine in AdultsFDA approved new migraine prevention drug Vyepti given by IV every 3 months

FDA From the archive Source published February 21, 2020 Summary added June 9, 2026 DOI ↗ Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain

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Key Takeaway

Consider Vyepti as an intravenous preventive treatment for migraine in adults, dosed every 3 months.

The FDA has approved Vyepti (eptinezumab-jjmr) for the preventive treatment of migraine in adults, offering a new intravenous option for patients who require prophylaxis. Vyepti is a calcitonin gene-related peptide (CGRP) antagonist administered as a 30-minute intravenous infusion every 3 months. The approval was based on three randomized, placebo-controlled trials that included patients with episodic and chronic migraine. In Study 1, which enrolled patients with episodic migraine, both the 100 mg and 300 mg doses significantly reduced monthly migraine days compared to placebo over months 1-3. The 100 mg dose reduced migraine days by 3.9 days versus 3.2 days with placebo, and the 300 mg dose reduced by 4.3 days. Clinicians should note that Vyepti requires dilution and administration via intravenous infusion with an in-line filter, and it must be used within 8 hours of preparation.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Vyepti (eptinezumab-jjmr) is a calcitonin gene-related peptide antagonist.

Indication & Patient Population

Vyepti is indicated for the preventive treatment of migraine in adults.

Dosing & Administration

The recommended dosage is 100 mg administered by intravenous infusion every 3 months. Some patients may benefit from a dosage of 300 mg every 3 months. Vyepti must be diluted before use. For the 100 mg dose, withdraw 1 mL from a single-dose vial and inject into a 100 mL bag of 0.9% Sodium Chloride Injection. For the 300 mg dose, withdraw 1 mL from each of 3 vials and inject the resulting 3 mL into a 100 mL bag. Infuse over approximately 30 minutes using an intravenous infusion set with a 0.2 or 0.22 micron in-line or add-on sterile filter. Do not administer as an intravenous push or bolus. After infusion, flush the line with 20 mL of 0.9% Sodium Chloride Injection. The diluted solution must be infused within 8 hours and stored at room temperature. Do not freeze.

Key Clinical Trial Data

Efficacy was evaluated in three randomized, multicenter, placebo-controlled double-blind studies. Study 1 included patients with episodic migraine (4 to 14 headache days per month). Patients received placebo, 100 mg Vyepti, or 300 mg Vyepti every 3 months for 12 months. The primary endpoint was change from baseline in mean monthly migraine days over Months 1-3. Results: Vyepti 100 mg: -3.9 days (difference from placebo -0.7, p=0.018); Vyepti 300 mg: -4.3 days (difference -1.1, p<0.001); Placebo: -3.2 days. For ≥50% responder rate: 49.8% (100 mg), 56.3% (300 mg), 37.4% (placebo). For ≥75% responder rate: 22.2% (100 mg, not statistically significant), 29.7% (300 mg, p<0.001), 16.2% (placebo). Study 2 included patients with chronic migraine; Study 3 evaluated a single dose in patients with concurrent migraine. Trial data for Studies 2 and 3 not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Vyepti provides an intravenous option for migraine prevention, administered every 3 months. It may be considered for patients who prefer or require intravenous therapy. The label does not provide comparative data with other preventive treatments.

The FDA has approved a new drug called Vyepti (eptinezumab-jjmr) to help prevent migraines in adults. Vyepti is given as an intravenous (IV) infusion that takes about 30 minutes and is repeated every three months. It works by blocking a protein called CGRP that is involved in migraine attacks.

Vyepti is for people who have migraines often and need a preventive treatment. In clinical studies, patients who received Vyepti had fewer migraine days per month compared to those who received a placebo. For example, in one study of people with episodic migraine, those taking the 100 mg dose had about 3.9 fewer migraine days per month, while those on placebo had 3.2 fewer days.

This approval gives patients a new option that is given by IV rather than as a daily pill or injection. However, Vyepti does not stop a migraine that has already started. It is meant to be used regularly to reduce the number of migraines over time.

If you are interested in Vyepti, talk to your doctor. They can help you decide if this treatment is right for you based on your migraine history and health needs. Your doctor will also explain how the infusion works and what to expect during and after the treatment.

What this means for you:

Vyepti is a new IV migraine prevention option given every 3 months; talk to your doctor to see if it is right for you.

Study Details

Study typeFda approval

PublishedFeb 2020

View Original Abstract ↓

1 INDICATIONS AND USAGE VYEPTI is indicated for the preventive treatment of migraine in adults. VYEPTI is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults ( 1 )

FDA approved Vyepti (eptinezumab-jjmr) for Preventive Treatment of Migraine in AdultsFDA approved new migraine prevention drug Vyepti given by IV every 3 months

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FDA approved Vyepti (eptinezumab-jjmr) for Preventive Treatment of Migraine in AdultsFDA approved new migraine prevention drug Vyepti given by IV every 3 months

Study Details

Intravenous tenecteplase improves functional outcomes but increases hemorrhage risk in non-large vessel occlusion acute ischemic stroke

Tenecteplase improves stroke recovery but increases bleeding risk in late treatment window

Clinical research that matters. Delivered to your inbox.

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