General Information

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

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

Vyepti is supplied as a solution for intravenous administration. Vyepti requires dilution prior to administration. The recommended dose is 100 mg administered by intravenous infusion every 3 months. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 3 months.

Clinical Trials

FDA Approval

The FDA approval of Vyepti was based on two phase III randomized, placebo controlled clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine). In both studies, patients were randomized to receive placebo, Vyepti 100 mg, or Vyepti 300 mg. The primary endpoint was the change from baseline in mean monthly migraine days (MMD) over months 1-3. Patients were allowed to use concurrent acute migraine or headache medications. 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 or Vyepti 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. The Mean change from baseline in MMD with Vyepti compared with placebo from months 1-3 was: -3.9 days for 100 mg, -4.3 days for 300 mg and -3.2 days for placebo. Percent responders with at least 50 percent reduction in MMD in months 1-3 compared with placebo: 49.8 percent for 100 mg, 56.3 percent for 300 mg and 37.4 percent for placebo. Percent responders with at least 75 percent reduction in MMD in months 1-3: 22.2 percent for 100 mg , 29.7 percent for 300 mg and 16.2 percent for placebo. In addition, a greater percentage of placebo-treated patients had migraine on most days during the first 7 days of treatment compared to Vyepti -treated patients.

PROMISE-2: A total of 1,072 patients were randomized to receive placebo (N=366), 100 mg Vyepti (N=356) or 300 mg Vyepti (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 MMD compared with placebo months 1-3: -7.7 days for 100 mg, -8.2 days for 300 mg and -5.6 days for placebo. Percent responders with at least 50 percent reduction in MMD in months 1-3 compared with placebo: 57.6 percent for 100 mg, 61.4 percent for 300 mg and 39.3 percent for placebo. Percent responders with at least 75 percent reduction in MMD in months 1-3: 26.7 percent for 100 mg, 33.1 percent for 300 mg and 15.0 percent for placebo. A greater percentage of placebo-treated patients had migraine on each individual day during the first 7 days of treatment compared to Vyepti-treated patients.