EU CHMP recommend approval of Wakix (pitolisant) for narcolepsy- Bioprojet

The CHMP recommended granting a marketing authorisation for Wakix (pitolisant), from Bioprojet, for the treatment of narcolepsy.

Comment: The main treatments for narcolepsy are central nervous system stimulants such as methylphenidate, amphetamine, methamphetamine and Provigil (modafinil), from Lundbeck and Teva. First approved in the late 1990s, regulatory authorities have raised a number of safety concerns. Modafinil generics began to appear in 2011. To claw back revenue, Lundbeck and Teva developed a longer-acting form of modafinil called Nuvigil (armondafinil), approved in 2007. This is due to go off patent and Mylan will be allowed to sell generic versions in June 2016. The third main treatment is Xyrem (sodium oxybate), from UCB and Jazz Pharma, which was first approved 2002. As well as improving the quality of night-time sleep and daytime alertness, the drug has fewer serious side effects than modafinil-based treatments. The other notable treatment in Phase III trials is Vyvanse/Elvanse (lisdexamfetamine dimesylate), from Shire.