Biohaven’s oral migraine drug performed well in a pivotal clinical trial in China and South Korea, the company reported Monday.
Rimegepant, the New Haven biotech’s calcitonin gene-related peptide receptor antagonist, showed positive top-line results in a Phase 3 clinical trial involving 1,431 adults in the two countries, Biohaven reported.
Biohaven’s Chinese subsidiary, BioShin Limited, conducted the study to evaluate the orally dissolving tablet formulation of rimegepant. The study found that a single oral dose of 75 mg of rimegepant delivered “significant relief of migraine symptoms and return to normal function at two hours and delivered sustained efficacy that lasted up to 48 hours for many patients,” according to a company statement.
The latest trial was the first Phase 3 study of rimegepant for the acute treatment of migraine conducted in Asia and the fourth overall.
The results were announced in tandem with Pfizer, which has commercialization rights to the drug in markets outside of the U.S. Biohaven teamed up with Pfizer last month in a deal potentially worth $1.24 billion.
Biohaven CEO Vlad Coric said, “Through our partnership with Pfizer, we are committed to rapidly expanding the availability of rimegepant to patients around the world, particularly in Asia Pacific where migraine is a common disease and a leading cause of disability.”
Shengyuan Yu, principal investigator of the study and director of neurology at Chinese PLA General Hospital, said, “We need new, effective and safe treatment options to help improve the lives of our migraine patients in Asia and are encouraged by the positive results of this study.”
Rimegepant, sold as Nurtec ODT in the U.S., is currently under review by the European Medicines Agency, with a decision expected in the first half of this year.
Kuwait and the United Arab Emirates have approved rimegepant for acute treatment of migraine, and Israel has approved it for both acute and preventive treatment.
Contact Liese Klein at lklein@newhavenbiz.com.
