rimegepant

Rimegepant is a new active substance indicated for the acute treatment of migraine with or without aura in adults, and for the preventive treatment of episodic migraine in adults experiencing at least 4 migraine attacks per month. The recommended dose is 75 mg. The application for marketing authorization was submitted on 8 February 2021, and the CHMP adopted its assessment report on 24 February 2022, recommending the granting of the marketing authorisation.

In a Phase 3, multicentre, randomised, double-blind, placebo-controlled study, rimegepant demonstrated efficacy in treating migraine. For pain freedom at 2 hours, 19.6% of participants receiving rimegepant achieved this outcome, compared to 12.0% in the placebo arm. For freedom from most bothersome symptom (MBS) at 2 hours, 37.6% of rimegepant recipients achieved this, versus 25.2% in the placebo arm. Pain relief at 2 hours was reported by 58.1% of rimegepant recipients, compared to 42.8% in the placebo arm. Sustained pain freedom at 24 hours was observed in 12.3% of rimegepant recipients, versus 7.1% in the placebo arm.

Safety findings included dizziness, reported in 2.5% of participants in one study. Non-clinical studies indicated safety margins for various effects, such as a safety margin in rats (males) at NOEL/NOAEL to clinical dose (AUC) of ≥ 20x and in monkeys (males) to clinical dose (AUC) of ≥ 16x. Exposure multiples for specific toxicities were also noted, such as ≥ 95 times for intravascular hemolysis in rats and ≥ 12 times for hepatic lipidosis in mice.