FDA approves Lilly’s new migraine attack drug, rival from Allergan could follow
The FDA has approved Eli Lilly’s new migraine drug lasmiditan, offering patients a new option to relieve symptoms should they feel an attack coming on.
Under the brand name Reyvow, Lilly’s drug works with a different biological mechanism from the gang of recently-approved preventive drugs from such as Lilly’s Emgality (galcanezumab) and rivals from Novartis/Amgen and Teva.
Reyvow is the first drug approved from the serotonin (5-HT1F) receptor agonist class, in the increasingly competitive market for migraine medicines.
Lilly’s closest competitor is likely to be Allergan’s ubrogepant, which is a calcitonin gene-related peptide (CGRP) agonist drug like Emgality, but is used as an acute treatment like Reyvow.
An FDA decision on ubrogepant is due at the end of this year following a filing in early March and a standard 10-month review period.
As with all central nervous system medicines, the FDA required abuse potential studies for Reyvow, as the regulator is concerned about issues with addiction to prescription drugs because of the opioid crisis gripping many parts of the US.
Lilly’s abuse potential studies showed therapeutic doses of Reyvow were associated with less drug liking when compared to alprazolam but more than placebo.
The recommended controlled substance classification for Reyvow is under review by the Drug Enforcement Administration (DEA) and is expected within 90 days of the FDA’s approval on Friday.
The filing for Reyvow included data from two phase 3 single-attack studies (SAMURAI and SPARTAN), which evaluated the safety and efficacy of Reyvow for the acute treatment of migraine in adults.
Both studies met the efficacy endpoints of pain freedom and freedom from most bothersome symptom compared with placebo two hours after administration, where a patient selected from nausea, sensitivity to light, or sensitivity to sound.
Treatment emergent adverse events were generally mild to moderate and the most frequent included dizziness, fatigue, paresthesia (tingling or numbing sensation on the skin), sedation (sleepiness or drowsiness), nausea and/or vomiting and muscle weakness.
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