Following the news that US-based start-up Harmony Biosciences’ Wakix (pitolisant), a first-in-class drug for the treatment of excessive daytime sleepiness (EDS) in adult patients suffering from narcolepsy, has been approved by the FDA.

Sarah Elsayed, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:

“The launch of Wakix will be a welcome addition to the treatment landscape as it provides a new option for healthcare professionals to manage their patients effectively, overcome the current treatment’s high unmet needs, and increase disease awareness.

“The drug significantly improved the two major symptoms of narcolepsy, EDS and cataplexy, during studies. It will compete directly with Xyrem, a central nervous system depressant by Jazz Pharmaceuticals, which generated sales of $1.4bn in 2018 globally, according to GlobalData. However, Xyrem is a Schedule III controlled substance, unlike Wakix, which means the latter does not have a potential risk of abuse or dependence.

“Key opinion leaders (KOLs) interviewed by GlobalData believe that Wakix is not as effective as Xyrem, but it represents a valid alternative to patients who cannot tolerate Xyrem’s side effects and would, therefore, be relegated to second-line treatment.

“GlobalData forecasts Wakix to gain a small share of the narcolepsy market, valued at $1.5bn in 2018 in the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK and Japan).”