Breaking News: Eptinezumab-jjmr (VYEPTI™) Approved by FDA

Eptinezumab, the first intravenous treatment for migraine prevention, approved by the FDA

On February 21, 2020, the FDA approved eptinezumab-jjmr (VYEPTI™) for the preventive treatment of migraine in adults. This is the first intravenous (IV) treatment for migraine prevention and the latest in a new class of monoclonal antibodies used for the preventive treatment of migraine. 

The treatment was evaluated through two phase III clinical trials (PROMISE-1 in episodic migraine and  PROMISE-2 in chronic migraine), which demonstrated the efficacy and safety of eptinezumab. The primary endpoint was the change from baseline in mean MMD over months 1-3. 

Clinical Trials

In PROMISE-1, a total of 665 patients with episodic migraine were randomized to receive placebo, 100 mg eptinezumab, or 300 mg eptinezumab every 3 months for 12 months. The mean migraine frequency at baseline was approximately 8.6 migraine days each month. The results indicated that the mean reduction in migraine days from baseline to placebo was -3.9 days for 100 mg, -4.3 days for 300 mg and -3.2 days for placebo. 

In PROMISE-2, a total of 1,072 patients with chronic migraine were randomized to receive placebo, 100 mg eptinezumab, or 300 mg eptinezumab every 3 months for 6 months. The mean migraine frequency at baseline was approximately 16.1 migraine days per month. The results indicated that the mean reduction in migraine days from baseline to placebo was -7.7 days for 100 mg, -8.2 days for 300 mg, and -5.6 days for placebo.

Eptinezumab Side Effects

In PROMISE-1 and PROMISE-2, 1.9% of patients discontinued treatment due to adverse reactions. The most common adverse reaction during clinical trials was nasopharyngitis and hypersensitivity. Patients should be advised to discontinue use immediately if serious hypersensitivity occurs.

How Eptinezumab Works

Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. The drug is expected to launch commercially in April of 2020 and should be administered every three (3) months via a 30-minute IV infusion. 

For more information about eptinezumab that can be used to inform treatment decisions, click here.

This is yet another very exciting development for people living with migraine.