MHRA Authorisation for Orladeyo™▼ (berotralstat) for HAE patients in Great Britain

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for ORLADEYO™ (berotralstat) for routine prevention of recurrent Hereditary Angioedema (HAE) attacks in HAE patients 12 years and older in Great Britain (England, Scotland, and Wales)

Berotralstat is the first and only oral inhibitor of plasma kallikrein in a once-daily 150 mg capsule; indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older in Great Britain. HAE is estimated to impact 1,000 to 1,500 patients in the UK.