The Food and Drug Administration (FDA) recently approved a new indication for Jazz Pharmaceuticals’ Xywav for the treatment of patients with idiopathic hypersomnia (IH), a rare neurologic disorder that can result in daytime sleepiness despite having a prolonged night sleep. The expanded use of Xywav in IH will further bolster the drug’s position ahead of the competition and help Jazz hold its lead in the narcolepsy market, says GlobalData, a leading data and analytics company.

Sarah Elsayed, Neurology Analyst at GlobalData, comments: “Jazz is expected to undertake a switching strategy from Xyrem to its new brand Xywav, in order to offset Xyrem’s sales decline due to generics erosion as the brand approaches the loss of patent exclusivity in 2023. Since Xywav’s first approval in July 2020 in narcolepsy, its uptake in the US has soared, driven mainly by the favorable safety profile of its lower sodium reformulation compared to its predecessor, Xyrem. Given Xywav’s strong clinical and commercial profile, GlobalData expects its exponential growth trajectory to continue into 2027 reaching $1.3bn in global sales.

“However, Xywav is still expected to face significant competition from recently launched products in the US, including Jazz’s Sunosi (solriamfetol) and Harmony’s Wakix (pitolisant), both approved by the FDA in 2019. Some key opinion leaders (KOLs) previously interviewed by GlobalData indicated that Sunosi has demonstrated superior efficacy in treating excessive daytime sleepiness (EDS), a particularly challenging aspect of narcolepsy treatment, however, it is not effective in treating cataplexy.”

Additionally, KOLs believed that Wakix is not as effective as sodium oxybate drugs (Xyrem and Xywav), but it represents a valid alternative to patients who cannot tolerate their side effects and would, therefore, be relegated to second-line treatment. As such, Xywav’s key competitive advantage is its enhanced safety and tolerability in patients with cardiovascular diseases due to the low-sodium formulation, in addition to its efficacy to treat symptoms of narcolepsy with cataplexy and being the only drug approved in IH to date.

Elsayed adds: “However, a few barriers to its uptake do exist. For example, Xywav is a Schedule III controlled substance, which means that it has a potential risk of misuse or dependence. Therefore, the drug will only be available through a restricted program known as Risk Evaluation Mitigation Strategy (REMS). The company plans to make the drug available for IH patients by the end of 2021 following the REMS implementation. These barriers notwithstanding, GlobalData anticipates Xywav to be Jazz’s next blockbuster over the next few years in the narcolepsy and sleep disorder market.”