Narcolepsy is relatively rare, affecting just one in 2000 people, and affecting men and women equally. It’s a condition characterised by 'sleep attacks' during the day, where you suddenly fall asleep without control. Narcolepsy is a neurological condition which affects your brain’s control over when you sleep.
Following this positive CHMP opinion, the Committee for Orphan Medicinal Products ( COMP) will assess whether the orphan designation should be maintained.Edited by: Conor Dunworth What is narcolepsy?.The applicant for Wakix is Bioprojet Pharma.Once a marketing authorisation has been granted, each Member State will take a decision on price and reimbursement based on the potential role/use of this medicine in the context of its national health system. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. The opinion adopted by the CHMP at its November 2015 meeting is an intermediary step on Wakix's path to patient access. In addition orphan designation gives medicine developers access to incentives, such as fee reductions for marketing authorisation applications and scientific advice. Orphan-designated medicines qualify for ten years' market exclusivity. Orphan designation is the key instrument available in the European Union (EU) to encourage the development of medicines for patients with rare diseases. In addition, the CHMP requested the company to carry out a long-term safety study in order to further investigate the safety of the medicine when patients use it over long periods of time.īecause narcolepsy is rare, Wakix received an orphan designation from the Committee for Orphan Medicinal Products ( COMP) in 2007. Insomnia, headache and nausea were among the most common side effects observed in the clinical trials and the CHMP decided on measures to mitigate these risks. The studies did not identify major safety concerns with Wakix. The beneficial effect of Wakix on cataplexy was shown in one of the pivotal studies as well as in the supportive study. The studies showed that Wakix was effective in reducing excessive daytime sleepiness in patients with narcolepsy. Its recommendation to authorise Wakix for narcolepsy patients with or without cataplexy was based on the examination of two pivotal placebo-controlled studies involving 259 patients, as well as one uncontrolled, open-label study in 102 patients with narcolepsy and one supportive study in 105 patients. This leads to increased histamine release in the brain, thereby enhancing wakefulness and alertness.ĮMA's Committee for Medicinal Products for Human Use ( CHMP) evaluated all available data on the safety, efficacy and quality of Wakix. It is a first-in-class medicine that acts on histamine H3 receptors in the brain. Wakix will add to the available treatment options for narcolepsy. In addition, some patients may experience sudden episodes of a related condition, cataplexy, potentially causing dangerous falls and increasing the risks of accidents, including car accidents.
TREATMENT OF CATAPLEXY PROFESSIONAL
Narcolepsy symptoms can be very severe and can have a significant impact on the private and professional life of patients. This can lead to symptoms such as excessive daytime sleepiness including the sudden urge to sleep, and disturbed night-time sleep. Narcolepsy is a rare, long-term sleep disorder which affects the brain's ability to regulate the normal sleep-wake cycle. The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Wakix (pitolisant) for the treatment of narcolepsy with or without cataplexy (sudden severe muscle weakness or loss of muscle control). Wakix to target excessive daytime sleepiness and cataplexy
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