Ubrelvy's a winner, but not for long

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Allergan’s Ubrelvy (ubrogepant) has become the first oral CGRP antagonist to be approved for acute migraine - but its place in the market will be less ground-breaking. Biohaven has a US action date set for the first quarter for its rival, Zydis ODT, a fast-acting formulation of the oral CGRP rimegepant. With the usual caveats about cross-trial comparisons Zydis ODT arguably looks better at the endpoint of the proportion of patients who were pain-free two hours after treatment, while Lilly’s recently approved Reyvow, a 5-HT1F agonist, looks even better, although it is burdened with side effects and DEA scheduling. Ubrelvy has a more favourable safety profile, with repeated dosing allowed if needed, and a lack of any liver toxicity on its label. This bodes well for Biohaven as the oral CGRP class had been plagued by safety issues in the past.

Phase III acute migraine data
Drug Ubrelvy Zydis ODT Reyvow
Study Achieve-1 303 Spartan Samurai
Dose (mg) 100 75 200 200
% of responders pain-free at 2 hours, placebo-adjusted 9.4 10.3 17.5 16.9
P value <0.001 <0.0001 <0.001 <0.001
NB: Table includes highest doses tested only. Source: company releases.

 

Biggest expected acute migraine products in 2024
Product Company Pharma class 2024e sales ($m) Status
Zydis ODT/
rimegepant tablet
Biohaven CGRP antagonist 897 Filed (acute)
phase III (preventative)
Reyvow Lilly 5-HT1F agonist 317 Approved
Ubrelvy (ubrogepant) Allergan CGRP antagonist 302 Approved
Source: EvaluatePharma & company releases.

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