UK Early Access For BioCryst’s Hereditary Angioedema Drug
Berotralstat Could Overcome ‘Serious Limitations’ Of Existing Therapies
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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BioCryst & Celgene Suffer English Funding Setback For Rare Disease Drugs
Orladeyo and Inrebic have been approved in Great Britain but they will not be available under the National Health Service unless their manufacturers can convince the health technology assessment body, NICE, that their products are cost-effective.
BioCryst’s Oral Option To Take On Injectables In HAE Prophylaxis Market
Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.
EU Accelerated Assessment Tracker
Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.