After Lilly’s acute migraine drug Reyvow (ingredient: lasmiditan) obtained the license from the U.S. Food and Drug Administration in October, Allergan’s Ubrelvy (ubrogepant) followed suit recently.
The competition in the acute migraine treatment market is likely to get fierce if Biohaven wins the nod for rimegepant, Ubrelvy’s strongest rival, in the first quarter of next year.
The FDA gave the green light to Allergan’s Ubrelvy for the treatment of acute migraine with or without aura in adults. The drug is an orally-administered calcitonin gene-related peptide (CGRP) receptor, antagonist.
Ubrelvy is the first acute migraine drug to win the license with a mechanism of suppressing CGRP.
Lilly’s Reyvow is a 5-hydroxytryptamine receptor 1F (5-HT1F receptor) agonist, which has excellent pain relief effects. However, it affects the central nervous system, which makes the drug subject to Drug Enforcement Administration regulations and exposes patients to worries over side effects.
As drug companies have found that CGRP is the neurotransmitter most closely related to migraine attacks, they have developed treatments with a CGRP inhibiting mechanism for acute migraines, in addition to preventive drugs.
Although Ubrelvy won the “first drug” title, another CGRP receptor antagonist – Biohaven’s rimegepant -- is expected to arrive in the market in the first quarter of next year.
According to each company’s clinical trials submitted to the FDA for approval, 9.4 percent of Ubrelvy-treated patients reported pain freedom at two hours (Achieve-1 trial), and 10 percent of rimegepant-treated patients did so (303 trial).
The Spartan and Samurai studies on Reyvow showed that 16.9 percent and 17.5 percent of Reyvow-treated patients reported pain relief at two hours, respectively.
However, patients are banned from taking opioids, tranquilizers, and triptans within 24 hours after taking Reyvow, which has side effects in the central nervous system. Thus, other CGRP receptor antagonists may have the upper hand because they can be re-administered with stronger safety profiles.
EvaluatePHarma, a global pharmaceutical market researcher, forecast that rimegepant would raise $897 million in annual sales in 2024, Reyvow, $317 million, and Ubrelvy, $302 million.
In Korea, Ildong Pharmaceutical acquired the sales rights of lasmiditan and began a phase-3 study to seek approval from the Ministry of Food and Drug Safety. The Korean drug company acquired the sales rights of lasmiditan in eight Asian countries from the drug developer CoLucid Pharmaceuticals, which was later acquired by Lilly.