Research & Development
Harmony Biosciences' WAKIX receives US FDA approval
15 October 2020 -

United States-based Harmony Biosciences Holdings Inc. (Nasdaq: HRMY) has received approval from the United States Food and Drug Administration (FDA) for WAKIX (pitolisant) intended for the treatment of cataplexy in adult patients with narcolepsy, it was reported on Wednesday.

The product is the first and only treatment approved by the US FDA for patients with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the US Drug Enforcement Administration (DEA).

IT is a first-in-class medication and a selective histamine 3 (H3) receptor antagonist/inverse agonist that works via a novel mechanism of action to increase the synthesis and release of histamine. It is administered orally, once daily in the morning upon wakening. FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomised, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX.

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