Biopharmaceutical company Biohaven Pharmaceutical Holding Company Ltd (NYSE:BHVN) and its BioShin wholly-owned Asia-Pacific subsidiary company on Monday announced the joint filing of an investigational new drug (IND) application, for rimegepant to treat migraine, with the National Medical Products Administration (NMPA).

Rimegepant, which is Biohaven's lead oral calcitonin gene-related peptide (CGRP) receptor antagonist product candidate, is being developed as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. CGRP receptor antagonists offer an alternative to current agents, particularly for patients who have contraindications to the use of triptans, such as those with underlying cardiovascular diseases.

The company added that the efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomised controlled trials to date: the three completed pivotal Phase 3 trials and a Phase 2b trial. The co-primary endpoints achieved in the three Phase 3 trials are consistent with regulatory guidance from the US Food and Drug Administration (FDA) and provide the basis for a planned submission of a new drug application (NDA) to the FDA in 2019.

In addition, the World Health Organisation's (WHO) 2015 Global Burden of Disease Study ranks migraine as the third most prevalent disease in the world and the seventh highest specific cause of disability worldwide. Migraine affects approximately 9-10% of the adult population in China, comprising approximately 80 to 90 million adults.