Pfizer and Biohaven’s Vydura get EC nod for Migraine treatments.

Pfizer Inc. and Biohaven Pharmaceutical Holding Company Ltd. have announced that the European Commission (EC) has recently granted marketing authorization for Vydura (rimegepant) and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month.

Vidura (rimegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraine with or without aura. It is an orally disintegrating tablet and is the first medicine approved for sensitive and prophylactic migraine treatment in the European Union (EU). Migraine, the reader must note, is a leading cause of disability worldwide, with approximately one in every ten people living with the condition in Europe alone. Globally, migraine disproportionately affects women three to four times compared men.

“There is a significant unmet need for people in the European Union living with the pain and disability caused by frequent migraines,” commented Nick Lagunowich. “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. In contrast, 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.” He is the global president at Pfizer Internal Medicine.

Results from the phase 3 study published in Lancet demonstrated that a single dose of rimegepant provided superior pain reduction and associated migraine symptoms at two hours compared to a placebo. The prevention study, also published in Lancet, demonstrated that rimegepant took every other day provided a superior reduction in the number of days per month with migraine in Weeks 9 –12 of the 12-week treatment period compared to placebo, which was maintained with continued dosing during the 12-month open-label extension period.

“Today’s approval marks a huge step forward for patients in Europe living with migraine. Migraine is often overlooked and undertreated, resulting in substantial disability with suboptimal care for patients,” commented Professor Peter Goadsby. “Vydura’s promising efficacy and favorable benefit-risk profile spark hope for people in need of new migraine treatment options. This approval has the potential to advance the standard of care for migraine in the EU, and I am hopeful it will improve the quality of life for many people living with the burden of this prevalent neurological disease.” He is director of the National Institute for Health and Care Research (NIHR) Clinical Research Facility and Professor of Neurology at King’s College London.

In February, the Marketing Authorization will follow the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The European Commission (EC) approval will be valid for all 27 European Union (EU) member states as well as countries like Iceland, Liechtenstein, and Norway, and further local reimbursement approval will follow. Assessment of the marketing authorization application provided by the Medicines & Healthcare products Regulatory Agency (MHRA) is underway, and approval from the same is expected to follow in the United Kingdom shortly.

Vidura is an innovative solution that targets a key migraine component by reversibly blocking CGRP receptors. CGRP is known to increase during a migraine attack; it dilates blood vessels and is also known to be involved in nociceptor signaling. CGRP receptor antagonists reversibly block CGRP receptors. Thus they inhibit the biological activity of the endogenous CGRP neuropeptide.

The marketing authorization for Vydura was partially based on the review of the results from three phases 3 studies analyzing the acute treatment, a long-term, open-label safety study in the acute treatment of migraine, and a phase 3 study with a 1-year open-label extension in the preventive treatment of migraine. Vidura can be taken orally as needed, but only up to once daily, to stop migraine attacks, and it can also be taken every other day to help prevent migraine attacks.