Harmony Biosciences announced a continued increase in the usage of its narcolepsy drug Wakix (pitolisant) during the fourth quarter of 2023. 

The company reported that the average number of patients using Wakix increased by approximately 350 sequentially to approximately 6,150 in the fourth quarter. Preliminary, unaudited net product revenue for the fourth quarter was approximately $168 million, compared to $128.3 million for the same period in 2022, representing approximately 31% growth.

“We enter 2024 poised to generate up to $720 million in net revenue and are well on our way toward a $1 billion-plus opportunity for Wakix in adult narcolepsy alone. Leveraging our strong cash position, as well as our expertise in clinical development and commercial execution, we will continue to advance our growth strategy by adding new products to build out a robust pipeline,” says Jeffrey M. Dayno, MD, Harmony president and CEO, in a release.

Harmony Biosciences highlighted its ongoing efforts in clinical development and portfolio diversification. Key 2024 priorities include: 

  • Continued strong growth for Wakix in adult narcolepsy
    • Drive commercial strategy to achieve net revenue over $700 million
    • Grow the average number of patients on Wakix to approximately 7,000
    • Increase educational outreach to drive continued growth in depth and breadth of the prescriber base and patient interest in Wakix
  • Advance and Expand the Pipeline
    • Report pharmacokinetic data on new pitolisant-based formulations in the first half of 2024
    • Initiate the phase 3 TEMPO study in Prader-Willi syndrome in Q1 2024
    • US Food and Drug Administration (FDA) meeting request submitted to discuss idiopathic hypersomnia path forward, with a meeting anticipated in Q1 2024
    • Complete the review of positive myotonic dystrophy type 1 phase 2 proof-of-concept data in excessive daytime sleeping and fatigue; assess opportunity

Wakix, a first-in-class medication, is FDA-approved for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy and has been commercially available in the US since Q4 2019. 

It was granted Orphan Drug designation for the treatment of narcolepsy in 2010 and breakthrough therapy designation for the treatment of cataplexy in 2018.