New molecular entity
Development and Regulatory status
Nov 19 · The NDA was submitted on the basis of results from the PIII BHV-3000-301, BHV3000-302 and BHV3000-303 trials .
Nov 19 · FDA assigns PDUFA action date of Q1 20 for orally dissolving tablet formulation of rimegepant. Biohaven plans US launch Q1 20 .
Jul 19 · Has been filed in the US .
May 19 · Biohaven announces in its quarterly report that in Feb 18, a request for scientific advice for rimegepant was submitted to the Committee for Medicinal Products for Human Use and feedback was received in Jun 18. Based on this feedback, they believe there are several potential pathways to approval .
Mar 19 · Biohaven has successfully conducted a pre-NDA submission meeting with the US FDA & secured a US FDA priority review voucher (PRV), which it will submit alongside its NDA for rimegepant for the treatment of migraine, Q2 19. The basis of NDA submission will be the PIII BHV-3000-301, BHV3000-302 and BHV3000-303 trials .
Jun 18 · Biohaven enters into an exclusive worldwide license agreement with Catalent UK Swindon Zydis Limited (a subsidiary of Catalent Inc), to provide Zydis® ODT (orally disintegrating tablet) fast-dissolving formulation technology, for developing rimegepant and other small molecule CGRP receptor antagonists .
May 18 · Biohaven has an exclusive, worldwide license agreement with Bristol-Myers Squibb for all development and commercialisation rights to rimegepant .
Mar 18 · Biohaven expects to file with the US FDA in 2019.
Jul 17 · Two pivotal PIII trials initiated in the US (NCT03235479, NCT03237845), with expected primary completion dates early in 2018 .
Calcitonin gene-related peptide (CGRP) receptor antagonist, orally-active small molecule
Numbers may be misleading, as many who experience migraine do not consult their GP, but migraine affects about 6% of men and 18% of women. In children it is more common in boys than in girls. The first attack is often in childhood and over 80% have had their first attack by the age of 30 .
Trial or other data
Jul 19 · Results of PIII NCT03461757 are published; RCT (n=1466) reported that at 2 h postdose, rimegepant, an investigational calcitonin gene-related peptide receptor antagonist, was superior to placebo for freedom from pain (21% vs 11%, p<0.0001) and freedom from the most bothersome symptom (35% vs 27%, p=0.0009) .
Jul 19 · Results of NCT03237845 RCT (n=1186) are pulished; the study found rimegepant resulted in higher percentage of patients who were free of pain (19.6 vs. 12.0%; p<0.001) and free from most bothersome symptom (37.6 vs. 25.2% p<0.001) than placebo 2 hours after receiving dose. Most common adverse events were nausea and UTI .
Dec 18 · Pooled safety data released by Biohaven Pharmaceuticals for BHV-3000-301 (NCT03235479), BHV3000-302 (NCT03237845) and BHV3000-303 (NCT03461757) trials .
Oct 18 · Biohaven completes a PIII trial and evaluate the efficacy and safety of orally disintegrating tablet (ODT) formulation of rimegepant (the fast-dissolve Zydis®) in the treatment of acute migraine (BHV3000-303; NCT03461757). The randomised, double-Blind, placebo controlled trial was initiated in February 2018 and enrolled 1,466 patients in the US .
Mar 18 · Positive top-line results from two PIII trials (NCT03235479, NCT03237845) of rimegepant for migraine. In both trials, rimegepant met the co-primary efficacy endpoints of superiority to placebo at 2 hours after dosing in pain freedom and freedom from most bothersome symptoms such as nausea or sensitivity to light or sound. The rate of pain freedom in the 2 trials was 19.2% and 19.6% vs. 14.2% and 12% for placebo. Freedom from most bothersome symptoms was 37.6% and 36.6% v.s 25.2% and 27.7% in the placebo arm.
Feb 18 · Biohaven initiates a third PIII efficacy study of rimegepant, for the treatment of migraine. The study is expected to complete in Q4 18 .
Nov 17 · Biohaven announces completion of enrollment in PIII study BHV3000-302 (NCT03237845). Together with PIII study BHV3000-301 (NCT03235479), the trials enrolled approximately 3,000 pts with migraine. Topline results are expected in Q1 of 2018. Long-term safety data will be evaluated in a third trial, Study BHV3000-201.[4,5]
Jul 17 · Two pivotal PIII randomised placebo-controlled trials initiated (NCT03235479, NCT03237845), both recruiting solely in the US. Both have the same design, with estimated recruitment of 850 patients each, and twin primary outcomes: freedom from pain at two hours, and freedom from the most bothersome symptom of nausea, phonophobia or photophobia, vs. placebo. Estimated completion for both trials is early February 2018 .