Ubrelvy(Ubrogepant)

Ubrogepant (Ubrelvy) is an NDA-approved drug for the treatment of migraine. The application for Ubrogepant (NDA211765) was submitted on December 26, 2018, and received a Standard Review Priority, with the review completed on December 19, 2019.

In clinical trials, ubrogepant demonstrated efficacy in achieving pain freedom at 2 hours. For the 50 mg dose, 19.2% of patients achieved pain freedom at 2 hours, compared to 11.8% for placebo, with an Odds Ratio of 1.8 (adjusted p-value = 0.0023). For the 100 mg dose, 21.2% of patients achieved pain freedom at 2 hours, compared to 11.8% for placebo, with an Odds Ratio of 2.0 (adjusted p-value = 0.0001). The Number Needed to Treat (NNT) for pain freedom at 2 hours was 13.5 for ubrogepant 50 mg versus placebo and 10.6 for ubrogepant 100 mg versus placebo. Additionally, absence of most bothersome symptom (MBS) at 2 hours was observed in 38.2% of patients receiving ubrogepant 50 mg (Odds Ratio 1.7, adjusted p-value = 0.0023) and 37.7% of patients receiving ubrogepant 100 mg (Odds Ratio 1.6, adjusted p-value = 0.0023), compared to 27.8% for placebo.

The safety profile of ubrogepant was evaluated in 3624 patients who received at least one dose, with 1567 patients receiving at least one dose of 100 mg. Common adverse events occurred with an incidence of ≥1%. The safety of treating more than 8 migraines per month has not been established.