Bioproject has received approval from the European Medicines Agency (EMA) for their Ozawade (pitolisant) to treat adult excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA). The approval is based on two Phase III clinical studies to study the response in people with OSA and found no cardiovascular events or major changes in blood patterns or heart rate were observed. Bioproject aims to improve wakefulness and reduce EDS in adult patients suffering from OSA who have not had success with other treatment alternatives.
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