An orally disintegrating tablet and a calcitonin gene-related peptide (CGRP) receptor antagonist, Vydrua got the marketing authorisation for acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults with monthly at least four migraine attacks.
It is claimed to be the first medicine approved for both acute and prophylactic treatment of migraine in the EU.
Approximately one in ten people live with migraine in Europe alone. Across the world, migraine impacts women by three to four times as against men.
Pfizer Internal Medicine global president Nick Lagunowich said: “There is a significant unmet need for people in the European Union living with the pain and disability caused by frequent migraines.
“The comprehensive clinical program has established Vydura’s efficacy and safety as both an acute and preventive treatment of migraine. Studies in acute migraine demonstrated a rapid and long-lasting relief of migraine headache and other symptoms with a single dose, while the prevention study found a significant reduction in migraine attacks with every other day dosing.
“We have great confidence in the positive impact Vydura could have on people living with this debilitating condition in the EU.”
Phase 3 trial results published in Lancet showed that a single dose of rimegepant offered superior pain reduction and related symptoms of migraine at two hours as against placebo.
The marketing authorisation comes after the recommendation for approval in February by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The approval by the EC will be valid for all 27 EU member states as well as Iceland, Liechtenstein, and Norway. Local reimbursement approval will follow suit.
Evaluation of the marketing authorisation application by the Medicines & Healthcare products Regulatory Agency (MHRA) is underway. Its approval is expected shortly in the UK.
Earlier this year, the two companies signed an agreement for the commercialisation of Vydura. As per the terms of the deal, Pfizer has commercialisation rights to rimegepant in markets outside the US, while Biohaven continues to lead research and development across the world and retains the US market.