language
All Categories >
CGRP receptor small molecule antagonists for migraine prevention are expected to be approved next year
2020-10-15
Biohaven Pharmaceutical announced today that the U.S. FDA has accepted the company's recent supplemental new drug application (sNDA) for Nurtec ODT (rimegepant) for the preventive treatment of migraine, with a response expected in the second quarter of next year. Nurtec is a small molecule CGRP receptor antagonist. The press release noted that Nurtec is expected to become a unique therapy that can be used for both preventive and acute treatment of migraine.
Migraine is a debilitating neurological disorder, ranking as the third most common disease worldwide and the seventh leading cause of disability globally. It is a disabling and recurrent condition, with attacks lasting from 4 to 72 hours, accompanied by various symptoms including pulsating, moderate to severe unilateral headache, which may be accompanied by nausea and/or vomiting, photophobia, and phonophobia.
Nurtec ODT is the first CGRP receptor antagonist with a fast-dissolving formulation, approved by the U.S. FDA for the acute treatment of migraine in adults. The activity of the neuropeptide CGRP is believed to play a causal role in the pathophysiology of migraine. Nurtec inhibits the biological activity of the CGRP neuropeptide by reversibly blocking the CGRP receptor.
This sNDA application is based on the results of the pivotal migraine preventive treatment trial (Study 305) in migraine patients, as well as the long-term, open-label safety study (Study 201) supporting the approval of Nurtec for acute migraine treatment.
Study 305 met its primary endpoint, showing that at month 3 of treatment, patients receiving Nurtec had a statistically significant reduction in monthly migraine days from baseline compared to placebo. Patients (n=348) experienced a reduction of 4.3 monthly migraine days from baseline, while the placebo group had a reduction of 3.5 days (n=347; p<0.05). Importantly, 49.1% of patients in the Nurtec group had at least a 50% reduction in the average number of moderate to severe migraine days per month from baseline, compared to 41.5% in the placebo group (p<0.05).
Tel：+86 13648401148
E-mail：wuhy@asincanbio.com
sales@asincanbio.com
wuhy51@hotmail.com
QQ：2665283306
Wechat：+86 13648401148
Skype：wuhy51
