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UK Early Access For BioCryst’s Hereditary Angioedema Drug

Berotralstat Could Overcome ‘Serious Limitations’ Of Existing Therapies

 
• By Ian Schofield

The HAE product, which meets the four criteria for pre-licensing use under the UK’s early access scheme, is currently undergoing regulatory evaluation in the EU, the US and Japan, with approval decisions expected in the last two countries next month.

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The UK EAMS unlocks access to unapproved drugs for unmet needs • Source: Shutterstock

BioCryst Pharmaceuticals, Inc.’s berotralstat has been given the go-ahead for pre-approval use in the UK for preventing recurrent attacks of the rare and potentially life-threatening disease, hereditary angioedema (HAE), under the Early Access to Medicines Scheme (EAMS).

The Medicines and Healthcare products Regulatory Agency has published a positive scientific opinion stating that berotralstat (Orladeyo) can be used in adult and adolescent patients aged 12 years and older, noting that under the EAMS the

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