Harmony Biosciences Holdings Inc provided business updates for the fourth quarter and full year ending Dec. 31, 2022, noting continued strong momentum for its commercial business of WAKIX (pitolisant) and its clinical development programs.
According to the company, the number of patients on WAKIX increased to approximately 4,900 by the end of Q4. Harmony also reported continued momentum in patient enrollment in the phase 3 registrational trial (INTUNE study) in adult patients with idiopathic hypersomnia, with approximately 85% of the planned clinical trial sites activated.
Regarding a pediatric narcolepsy indication, Harmony says its partner, Bioprojet, received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use on Jan. 26 and expects an approval for a pediatric narcolepsy indication from the EMA within 60 days of the positive opinion. The company also intends to work with Bioprojet on a path toward submitting a supplemental new drug application for pediatric narcolepsy to the US Food and Drug Administration.
As for pediatric exclusivity for WAKIX, Harmony received feedback from the US Food and Drug Administration on its Pediatric Written Request and will use it to prepare a proposed pediatric study request to submit to FDA to gain alignment with the agency, in pursuit of pediatric exclusivity for WAKIX.
Harmony closed the year with net product revenues of $437.9 million, 43.4% growth versus the same period in 2021, growth that was attributed to WAKIX’s increasing commercial sales, driven by continued organic demand.
“Looking ahead, we remain confident in the ongoing performance of WAKIX. Harmony remains a growth story, with the focus on advancement of our life cycle management programs for pitolisant and acquisition of new assets to build out our pipeline to drive additional growth. With that as our focus, I am excited to lead the company forward,” says Jeffrey M. Dayno, MD, interim CEO and chief medical officer of Harmony, in a press release.