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news.Eli Lilly has secured approval from the US Food and Drug Administration (FDA) for its Reyvow (lasmiditan) for the acute treatment of migraine.
Image: Eli Lilly and Company's Corporate Centre in Indianapolis, Indiana. Photo: courtesy of Momoneymoproblemz.
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Reyvow is a new oral medication for the acute treatment of migraine, with or without aura, in adults. It binds to 5-HT1F receptors with high affinity.
Reyvow is claimed to be the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin (5-HT)1F receptor agonists).
Lilly Bio-Medicines neurology development vice president Dr Gudarz Davar said: “Millions of people with migraine face an ongoing battle with the unresolved pain and symptoms of a migraine attack.
“There is a substantial unmet need for new acute treatments for migraine, like REYVOW, which is why we are proud of today’s approval and Lilly’s continuing contribution to the migraine community.”
The FDA requested abuse potential studies for Reyvow similar to other medicines with central nervous system (CNS) activity. Lilly carried out a human abuse potential assessment in line with the FDA’s guidance.
The therapeutic doses of Reyvow were linked with less drug liking compared to alprazolam, but more than placebo, said Lilly.
The Drug Enforcement Administration (DEA) is currently evaluating the recommended controlled substance classification for Reyvow.
Reyvow’s new drug application (NDA) is comprised of data from two phase 3 single-attack studies. The SAMURAI and SPARTAN studies assessed the safety and efficacy of Reyvow for the acute treatment of migraine in adults.
According to the company, both trials achieved the efficacy endpoints of pain freedom and freedom from most bothersome symptom at two hours following administration of Reyvow in comparison to placebo.
Reyvow phase 3 development programme, which also includes the open-label GLADIATOR study, recruited over 4,000 patients and treated more than 20,000 migraine attacks.
Lilly Bio-Medicines president and senior vice president Patrik Jonsson said: “For over 25 years, Lilly has been committed to helping people affected by disabling headache disorders, investigating more than a dozen different compounds.”
In August this year, Eli Lilly received approval for its monoclonal antibody Taltz (ixekizumab) from the FDA for the treatment of active ankylosing spondylitis (AS) in adults.
