USA – Biohaven Pharmaceutical Holding Co. and Pfizer Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of rimegepant, marketed in the United States as Nurtec ODT.
Oral CGRP is gaining popularity in the United States, putting pressure on the market potential of injectables from companies like Amgen and Lilly.
According to the companies, the recommendation covers a 75-milligram dose of rimegepant, which will be marketed as Vydura in the European Union.
Vydura is indicated for both the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least four migraine attacks per month.
The recommendation would now be reviewed by the European Commission, which generally follows CHMP’s advice.
The CHMP’s approval was based in part on the results of three Phase III trials in acute migraine treatment, including Study 303, which met its co-primary endpoints of pain freedom and freedom from the most bothersome symptom at two hours using a single dose.
Meanwhile, results from a late-stage study showed that the drug outperformed placebo on the primary endpoint, decreasing monthly migraine days by 4.3 days per month after three months of treatment.
According to the companies, vydura will be the first oral CGRP receptor antagonist approved in the EU, as well as the only migraine medication approved for both acute and preventive treatment.
Pfizer and Biohaven reached an agreement to commercialize rimegepant earlier this year. Pfizer has commercialization rights to rimegepant in markets other than the United States under the terms of the agreement.
Biohaven maintains its global leadership in research and development and its market share in the United States.
Migraine affects over one billion people worldwide, and the World Health Organization ranks it as one of the ten most disabling medical conditions.
Migraine is characterized by debilitating attacks that last four to 72 hours and include a variety of symptoms such as pulsating headaches of moderate to severe pain intensity, nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).
There is a significant unmet need for new treatments because more than 90% of migraine sufferers are unable to work or function normally during an attack.
In other news, VBI Vaccines’ trivalent hepatitis B vaccine PreHevbri—now known as PreHevbrio—was approved by the CHMP, with an official European Commission approval expected in the coming weeks.
Following an FDA approval in November, the CDC’s Advisory Committee on Immunization Practices recommended the vaccine for adult hepatitis B prevention.
The CHMP also approved Immunocore’s Kimmtrak for uveal melanoma, Idorsia’s insomnia drug Quviviq, Vifor Pharma’s Kapruvia for moderate-to-severe pruritus associated with chronic kidney diseases.
Myovant Sciences’ androgen deprivation therapy Orgovyx for hormone-sensitive prostate cancer also made it among the list of the approved drugs.
Myovant is currently working on Orgovyx with Pfizer in the United States, and the biotech has stated that if an official nod is given in Europe, it will sign with a partner there.