▼Pitolisant for narcolepsy

doi:10.1136/dtb.2017.1.0448

DTB

2017

DOI: 10.1136/dtb.2017.1.0448

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▼Pitolisant for narcolepsy

Abstract: ▼Pitolisant (Wakix-Bioprojet Pharma) is a new treatment for adults with narcolepsy with or without cataplexy. It was licensed for use in the EU in March last year and has orphan drug status. Here, we consider the evidence for pitolisant for the treatment of narcolepsy in adults and how it fits with current management strategies.

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2018

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Pathways to faster access to medicines

2018

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Before a medicine can be marketed in the UK, marketing authorisation approval is needed from the European Medicines Agency (EMA) or the Medicines and Healthcare products Regulatory Agency (MHRA). However, the time it takes to appraise a medicine is considered by some to delay access to new treatments for people with serious or life-threatening conditions who have no other treatment options. Also, the standard regulatory process may be less suitable for medicines for rare conditions in which it is difficult to gather a large amount of clinical trial data. Here we look at a range of new regulatory and access pathways that have been developed to respond to these challenges and consider some of their potential pitfalls. In a future article we will review the impact that the UK's departure from the European Union (EU) will have on licensing processes.

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Pathways to faster access to medicines

2018

DTB

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▼Pitolisant for narcolepsy

Cited by 1 publication

References 9 publications

Pathways to faster access to medicines

Pathways to faster access to medicines

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