Migraine prevention CGRP receptor small molecule antagonist is expected to be approved next year

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Time of issue:2020-10-15
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(Summary description)Biohaven Pharmaceutical announced today that the US FDA has accepted the company's recent supplementary new drug application (sNDA) for the preventive treatment of migraine for Nurtec ODT (rimegepant), and it is expected to respond in the second quarter of next year. Nurtec is a small molecule CGRP receptor inhibitor. The press release pointed out that Nurtec is expected to become a unique treatment that can be used for both preventive treatment and acute treatment of migraine.

Migraine prevention CGRP receptor small molecule antagonist is expected to be approved next year

(Summary description)Biohaven Pharmaceutical announced today that the US FDA has accepted the company's recent supplementary new drug application (sNDA) for the preventive treatment of migraine for Nurtec ODT (rimegepant), and it is expected to respond in the second quarter of next year. Nurtec is a small molecule CGRP receptor inhibitor. The press release pointed out that Nurtec is expected to become a unique treatment that can be used for both preventive treatment and acute treatment of migraine.

Categories:Industry News
Author:
Origin:
Time of issue:2020-10-15
Views:0

　　Biohaven Pharmaceutical announced today that the US FDA has accepted the company's recent supplementary new drug application (sNDA) for the preventive treatment of migraine for Nurtec ODT (rimegepant), and it is expected to respond in the second quarter of next year. Nurtec is a small molecule CGRP receptor inhibitor. The press release pointed out that Nurtec is expected to become a unique treatment that can be used for both preventive treatment and acute treatment of migraine.

　　Migraine is a debilitating neurological disease. It is the third most common disease in the world and the seventh most common cause of disability in the world. It is a disabling and recurrent disease, the onset time can be as long as 4 to 72 hours, and accompanied by a variety of symptoms, including: pulsating, moderate to severe pain intensity unilateral headache, may be accompanied by nausea and/or Vomiting, photophobia and noise.

　　Nurtec ODT is the first CGRP receptor antagonist with a fast-dissolving dosage form. It has been approved by the US FDA for the acute treatment of adult migraine. The activity of the neuropeptide CGRP is thought to play a causal role in the pathophysiology of migraine. Nurtec inhibits the biological activity of CGRP neuropeptide by reversibly blocking CGRP receptors.

　　The sNDA application is based on the results of a pivotal migraine preventive treatment trial for migraine patients (Study 305) and a long-term, open-label safety study (Study 201) that supports the approval of Nurtec for the acute treatment of migraine.

　　Study 305 reached its primary endpoint. In the third month of treatment, compared with placebo, the number of migraine days per month in the Nurtec-treated patient group was statistically significantly reduced compared to baseline, and patients (n=348) had monthly migraine The number of onset days decreased by 4.3 days from baseline, while the placebo group decreased by 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 days per month for moderate-to-severe migraine from baseline, compared with 41.5% in the placebo group (p<0.05).

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Migraine prevention CGRP receptor small molecule antagonist is expected to be approved next year

Migraine prevention CGRP receptor small molecule antagonist is expected to be approved next year

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