First-in-class migraine treatment approved by FDA
Posted: 16 October 2019 | Victoria Rees (European Pharmaceutical Review) | No comments yet
Reyvow (lasmiditan), for the treatment of acute migraine, has received approval from the FDA following success in clinical trials.
The US Food and Drug Administration (FDA) has approved Reyvow (lasmiditan) for the treatment of acute (active but short-term) migraine in adults.
The drug, which is produced by Eli Lilly and Company, is delivered orally via a tablet and is a first-in-class serotonin agonist. It binds to 5-HT1F receptor with high affinity; however, its exact mechanism of action is unknown.
The effectiveness of Reyvow was demonstrated in two randomised, double-blind, placebo-controlled trials. In both studies, the percentage of patients whose pain had resolved was significantly greater for those taking the medication rather than the placebo.
It binds to 5-HT1F receptor with high affinity; however, its exact mechanism of action is unknown”
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans,” said Nick Kozauer, MD, Acting Deputy Director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “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.”
Once available, REYVOW can be prescribed to patients in oral doses of 50mg, 100mg, and 200mg as needed.
Related topics
Drug Markets, Regulation & Legislation, Research & Development (R&D)
Related organisations
Eli Lilly and Company, US Food and Drug Administration (FDA)
