Berotralstat approved in EU for prevention of acute attacks in hereditary angioedema in patients 12 years and older
Approval was on the basis of the pivotal Phase 3 APeX-2 trial where this oral inhibitor of plasma kallikrein significantly reduced acute hereditary angioedema attacks during 48 weeks of treatment (2.9 attacks per month at baseline to 1.0 per month at week 48).
Source:
Biospace Inc.
SPS commentary:
In the United Kingdom, hereditary angioedema (HAE) patients also currently have access to berotralstat through an approved early access to medicines scheme (EAMS). A marketing authorization application has been submitted to the Medicines and Healthcare products Regulatory Agency (MHRA). Under the new European Commission Decision Reliance Procedure, the MHRA will aim to complete the review of the UK MAA as soon as possible following the EC approval decision.