(Reuters) – Biohaven Pharmaceutical Holding Company Ltd said on Tuesday two doses of its experimental treatment for acute migraine were effective in reducing headaches in a pivotal study.
The drug, vazegepant, belongs to a new class of treatments for migraine called CGRP inhibitors.
Vazegepant is the first CGRP treatment delivered in an intranasal formulation, which benefits patients uncomfortable with needles, the company said.
The trial evaluated the drug in three separate doses. Two higher doses reduced pain, helping patients return to normal function within two hours.
The positive results allow Biohaven to accelerate the program with only one additional positive efficacy trial likely needed for submission, the company said.
Vazegepant could generate revenue of $27 million in late 2021, and sales could reach $431 million by 2025, Wedbush analyst Laura Chico said.
Biohaven is racing against Allergan Plc to introduce a CGRP inhibitor for treatment of acute migraine.
The FDA is due to decide on Allergan’s application to market its oral treatment this month.
Injectable CGRP inhibitors such as Aimovig from Amgen Inc and Novartis AG, Emgality from Eli Lilly and Ajovy from Teva Pharmaceutical Industries Ltd recently won approval for use in migraine prevention.
Shares of Biohaven were trading down 1.14% at $54.51, reversing course after rising as much as 4%.
The FDA is scheduled to decide on the company’s lead product for acute treatment of migraine, rimegepant, by the first quarter of 2020.
Rimegepant, which is another CGRP inhibitor, is also being tested for prevention of migraine.
Vazegepant is complementary to rimegepant and has synergies with the product in terms of marketing, resources, and sales force, SVB Leerink analyst Marc Goodman said.
(Reporting by Manojna Maddipatla and Trisha Roy in Bengaluru; Editing by Saumyadeb Chakrabarty and Vinay Dwivedi)