UK drugmaker Vernalis and US partner Endo Pharmaceuticals have suffered a slight setback after US regulators said they need more time to consider the firms’ marketing application to expand the use of migraine drug Frova.
The US Food and Drug Administration has informed the companies that it will require an additional three months to review Endo's previously-submitted supplemental New Drug Application for Frova (frovatriptan) for the expanded indication of short-term prevention of menstrual migraine. The agency now anticipates completing its review of this application before August 19, rather than the original May 19 date. However the companies were quick to note that the FDA's request “relates solely to the presentation of the data and not its content and that no additional data have been requested.”
Frova was approved by the FDA to treat acute migraine attacks in November 2001 and Vernalis recently announced that it has received pricing and reimbursement for the treatment in this indication in France. A launch is planned for later this month there and partner Menarini will then market Frova in all of the major European pharmaceutical markets and apply for the menstrual migraine indication in the second half of the year.