Reyvow FDA approval : Eli Lilly and Company (Lilly) has bagged approval from the US Food and Drug Administration (FDA) for Reyvow (lasmiditan) for the acute treatment of migraine, irrespective of aura (a sensory phenomenon or visual disturbance), in adults.
The oral treatment, which has been designed to bind to 5-HT1F receptors with high affinity, has not been indicated for the preventive treatment of migraine.
According to the FDA, an aura appears as zig-zag lines, flashing lights, or a temporary loss of eyesight.
Commenting on Reyvow FDA approval, Nick Kozauer – acting deputy director of the Division of Neurology Products in the FDA Center for Drug Evaluation and Research, said: “Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans.
“We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine.”
Reyvow FDA approval has been driven by results from a couple of phase 3 single-attack studies called SAMURAI and SPARTAN, which assessed the safety and efficacy of the Lilly drug for the acute treatment of migraine in a total of 3,177 adult participants.
The two migraine trials achieved the efficacy endpoints of pain freedom and freedom from most bothersome symptoms at two hours after the drug administration compared to placebo.
The FDA cautioned that there Reyvow can cause driving impairment and therefore patients are advised against driving or operating machinery for a minimum of eight hours after taking the drug. This is even if the patients feel well enough to do so.
The US drug regulator added that patients who cannot follow the advice should not take Reyvow. The Lilly migraine drug causes central nervous system (CNS) depression, causing dizziness and sedation, and should be used cautiously if taken in combination with alcohol or other CNS depressants, said the FDA.
Lilly said that as with other drugs with CNS activity, the FDA asked for abuse potential studies for Reyvow and in line with that the company carried out a human abuse potential assessment.
The US pharma giant said that as part of that assessment, therapeutic doses of Reyvow were linked to less drug liking in comparison to alprazolam, but more than placebo. Lilly revealed that recommended controlled substance classification for the migraine drug is currently being reviewed by the Drug Enforcement Administration (DEA) with results to be disclosed within 90 days of the FDA approval, following which Reyvow will be available to patients across retail pharmacies.
Gudarz Davar – vice president, neurology development at Lilly Bio-Medicines, commenting on Reyvow FDA approval, 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.
“New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them. At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine.”
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