Biohaven Announces Acceptance of Investigational New Drug IND Filing for Rimegepant in China

Migraine TrialsiteN

Rimegepant(NYSE: BHVN) is an investigational drug candidate for the treatment of migraine. Originally discovered by Bristol-Myers Squibb, it is currently under development by Biohaven.  Based in New Haven, CT. Biohaven is a clinical-stage biopharmaceutical company, develops product candidates to treat neurological diseases, including rare disorders. Its lead product candidate is rimegepant, which is in Phase III clinical trials for the acute treatment of migraine. The company also develops trigriluzole, which is in a Phase II/III clinical trial used for the treatment of ataxias with an initial focus on spinocerebellar ataxia; and Phase II/III clinical trial for the treatment of obsessive compulsive disorders, as well as for the treatment of Alzheimer’s diseases. In addition, it develops BHV-3500 for the acute treatment and prevention of migraine; BHV-0223 for the treatment of amyotrophic lateral sclerosis, a neurodegenerative disease that affects nerve cells in the brain and spinal cord; and BHV-5000 for the treatment of symptoms associated with Rett syndrome, such as breathing irregularities. The company was founded in 2013 and is based in New Haven, Connecticut. The commercial sponsor announced that National Medical Products Administration (“NMPA”) (formerly, the China FDA) has accepted the investigational new drug (IND) application for rimegepant, Biohaven’s lead oral calcitonin gene-related peptide (CGRP) receptor antagonist product candidate, for the treatment of migraine. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class for the treatment of migraine in over 25 years. CGRP receptor antagonists potentially offer an alternative to current agents, particularly for patients who have contraindications to the use of triptans, such as those with underlying cardiovascular diseases, or those who have an inadequate response to standard therapies.