Harmony Biosciences Holdings Inc reported business updates for the quarter ended March 31, noting continued momentum in its commercial business for Wakix (pitolisant), as well as in the advancement of its clinical development programs for pitolisant for the treatment of idiopathic hypersomnia.
Wakix, a first-in-class medication approved by the US Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy, has been commercially available in the United States since Q4 2019.
“Wakix commercial performance reflects its unique and meaningfully differentiated product profile, allowing us to reach an important milestone of surpassing $1 billion in cumulative net revenue within the first three and half years since launch, one of the most successful launches ever for a rare disease company,” says Jeffrey M. Dayno, MD, president and CEO of Harmony, in a news release. “We have demonstrated strong and continued growth since the launch of Wakix and remain a growth story, given the vast opportunity that remains in the narcolepsy market, the potential of our current life cycle management programs, new formulations of pitolisant that are being developed, and growth through business development.”
According to the company, the average number of patients on Wakix increased by approximately 1,200 patients from the quarter ended March 31, 2022, to approximately 5,100 as of the quarter ended March 31.
Harmony’s partner Bioprojet received approval of a pediatric narcolepsy indication from the European Medicines Agency, and the company says in a release that it’s working with Bioprojet on the submission to the FDA of a supplemental new drug application for pediatric narcolepsy.
Regarding pediatric exclusivity, Harmony is working with the FDA to gain alignment in pursuit of pediatric exclusivity for WAKIX.
Additionally, the company reported continued strong momentum in the phase 3 registrational trial (INTUNE Study) in adult patients with idiopathic hypersomnia. Harmony expects topline data to be available in the fourth quarter of this year.