UK biotechnology firm Vernalis said today its application to market Frova drug as a treatment for preventing menstrual migraine in the USA has been accepted for review by the Food and Drug Administration.
The agency has now set a deadline of May 19, 2007, for its review. If approved, Frova (frovatriptan) would be the first drug in the triptan class to be given a green light in menstrual migraine.
Frova is already approved for other forms of migraine, with sales reaching $38 million in the USA last year. Analysts have suggested that the new indication could swell revenues from the drug to more than $250 million a year – a decent performance for a product that was a late entrant into the triptan market.
According to a deal signed in 2004 with Endo Pharmaceuticals, which sells the drug ion the USA, Vernalis stands to receive $40 million if Frova is cleared for menstrual migraine, as well as up to $255 million in sales milestones.