The Food and Drug Administration (FDA) is set to decide by Thursday on Plymouth Meeting-based Harmony Biosciences‘ application to expand the use of its flagship sleep disorder drug, Wakix, to include pediatric patients, writes John George for the Philadelphia Business Journal.
Initially approved in 2019 for adults with narcolepsy experiencing excessive daytime sleepiness or cataplexy, this approval would not only widen the patient base but also extend patent protection to 2030.
This six-month extension is crucial for Harmony as Wakix is projected to generate $700 million to $720 million in sales this year.
Harmony also plans to seek approval for pitolisant, Wakix’s active ingredient, for idiopathic hypersomnia, a rare sleep disorder.
In April, Harmony acquired Epygenix Therapeutics and entered a licensing deal with Bioprojet for a new narcolepsy drug candidate, TPM-1116. These deals, worth over $900 million combined, aim to expand Harmony’s drug pipeline.
Read more about Plymouth Meeting-based Harmony Biosciences in the Philadelphia Business Journal.
Learn about the INTUNE Clinical Trial with Director of Clinical Development at Harmony Biosciences
