Harmony Biosciences Holdings Inc reported second-quarter business updates, showcasing an upswing in prescription demand for its narcolepsy drug, Wakix.
Second-quarter growth was up 25% versus the same period in 2022, primarily attributed to strong commercial sales of Wakix driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients are diagnosed with narcolepsy in the US). The average number of patients on Wakix increased by approximately 350 sequentially to approximately 5,450 patients for the quarter. Harmony exited the quarter ended June 30 with approximately 5,600 patients on Wakix.
“This quarter represented the highest topline prescription demand since our first full quarter of launch in 2020 and the strongest quarter of new patient starts in our history,” says Jeffrey M. Dayno, MD, president and CEO of Harmony, in a release. “This sustained momentum in our core business, driven by robust underlying demand, reinforces our confidence in Wakix being a $1 billion-plus opportunity in narcolepsy alone.”
During the quarter, the company also completed enrollment of phase 3 registrational trial (INTUNE Study) in adult patients with idiopathic hypersomnia, nine months ahead of plan, and is on track for topline data in the fourth quarter.
Harmony also had a positive end-of-phase 2 meeting with the US Food and Drug Administration (FDA) and plans to initiate a phase 3 study in patients with Prader-Willi syndrome in the fourth quarter.
Regarding a pediatric narcolepsy indication, Harmony is working with Bioprojet on the submission to the FDA of a supplemental new drug application for pediatric narcolepsy. The company expects to submit the application later this year.
“We are actively pursuing pediatric exclusivity for WAKIX and have made progress with FDA in aligning on the requirements,” according to a release from the company.
