Vydura is indicated for acute treatment of migraine regardless of aura, and prophylaxis (prevention) of episodic migraine in adults who suffer at least four migraine attacks per month
The entrance to Pfizer World Headquarters in Manhattan, New York. (Credit: Coolcaesar/Wikipedia)
Pfizer and Biohaven Pharmaceutical have received the European Commission (EC) marketing authorisation for Vydura (rimegepant) to treat and prevent migraine.
Vydura is a calcitonin gene-related peptide (CGRP) receptor antagonist that targets migraine and is formulated as an orally disintegrating tablet.
The drug is indicated for acute treatment of migraine regardless of aura, and prophylaxis (prevention) of episodic migraine in adults who suffer at least four migraine attacks per month.
Earlier this year, Pfizer signed a collaboration and license agreement with Biohaven for the rights to market the latter’s migraine drugs outside of the US.
As per the agreement, Biohaven will exclusively market Vydura in the US, while Pfizer would commercialise the drug in all regions outside the US, subject to regulatory approval.
Vydura is the first treatment approved for both acute and prophylactic treatment of migraine in the European Union (EU), said the US drugmaker.
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.”
The EC approval follows a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), granted in February this year.
It will be valid for all 27 EU member states along with Iceland, Liechtenstein, and Norway and with local reimbursement approval expected soon.
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) is currently reviewing the company’s marketing authorization application.
The EC approval was partly supported by a review of the results from three Phase 3 studies in the acute treatment of and preventive treatment of migraine.
In the studies, treatment using a single dose of Vydura provided superior pain reduction and related symptoms of migraine at two hours, compared to placebo.
The drug offered a superior reduction in the number of days per month with migraine compared to placebo and was maintained during the 12-month open-label extension period.
Vydura is currently marketed in the US for the acute and preventive treatment of migraine and is approved in Kuwait and the UAE for the acute treatment of migraine, along with Israel.