A safety concern forced Takeda Pharmaceutical to suspend the dosing of patients in two Phase II studies of an experimental treatment for narcolepsy. The clinical trial halt came one day after the company forged a gene therapy agreement with Selecta Biosciences valued at $1.1 billion.
FDA Action Alert: Jazz, ANI and Ultragenyx
Approvals, Cataplexy, Excessive Daytime Sleepiness, Fatty Acids, FDA, FDA/Regulatory, Gels, Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Multiple Sclerosis, Narcolepsy, New Drug Applications, PDUFA, Refusal to File letter, Rheumatoid Arthritis, Supplemental New Drug Application (sNDA), Systemic Lupus Erythematosus (SLE), Ulcerative ColitisU.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
Dublin, Ireland-based Avadel Pharma announced positive topline data from the company’s pivotal Phase III REST-ON clinical trial of FT218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy.
An investigational medicine in late-stage development by Jazz Pharmaceuticals hit the mark in treating cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy.
Harmony Biosciences snagged approval from the U.S. FDA for the company’s first commercial product, a treatment for narcolepsy.