The United States Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity (ODE) to Jazz Pharmaceuticals plc’s Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia (IH) in adults, marking the medication’s second ODE after exclusivity was granted for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy.

Source: Jazz Pharmaceuticals plc

Idiopathic hypersomnia (IH) is a chronic neurologic disorder that manifests as pathologic daytime sleepiness with or without prolonged sleep durations. Population-based estimates of the frequency of IH are challenging to obtain, given the requirements for electrophysiologic testing and ruling out of other disorders that may cause similar symptoms. Differing referral patterns and biases limit Clinic-based estimates of IH prevalence. Estimates of the relative frequency of IH to narcolepsy with cataplexy vary substantially, anywhere from 1:10 to greater than 1:1. Family history of excessive sleepiness, IH, or another central disorder of hypersomnolence is seen in 34–38% of IH patients, with parent-child transmission suggested by the finding that 12.5% of IH patients have at least one parent who routinely sleeps more than 9.5 hours per night.

• Clinical features of IH and narcolepsy type 1 (NT1) are fairly distinct: patients with IH do not have cataplexy, while patients with NT1 do; patients with IH have high sleep efficiency with few nocturnal awakenings, while patients with NT1 have fragmented nocturnal sleep; patients with IH have long and unrefreshing naps, while patients with NT1 generally find short naps to be restorative.

However, the current Idiopathic hypersomnia (IH) treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (Pitolisant, TAK-925, Xywav®, and BTD-001) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Idiopathic hypersomnia (IH) treatment. The key companies in the advanced development stage are Harmony Biosciences, LLC, Takeda, Jazz Pharmaceuticals, and Balance Therapeutics.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook report on Idiopathic hypersomnia (IH) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2020 to 2030.

Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

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