BioCryst's berotralstat added to UK early access scheme

BioCryst Pharmaceuticals (Nasdaq: BCRX) revealed on Friday that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted oral, once-daily berotralstat a positive scientific opinion through the Early Access to Medicines Scheme (EAMS), with the news pushing the US biotech’s shares up 2.4% to $3.82 by close of trading.

Under the EAMS, hereditary angioedema (HAE) patients in the UK aged 12 years and older can gain access to berotralstat for the routine prevention of recurrent attacks of HAE before the drug is granted marketing authorization by the European Commission (EC). The drug is currently under review with the European Medicines Agency, with an advisory committee opinion expected around March next year.

“There are many patients in the UK that don’t have a realistic option for effective HAE prophylaxis. The addition of berotralstat through the EAMS will bring a much-needed option for HAE patients suffering with this debilitating disease,” said Dr Sorena Kiani, Consultant Immunologist at Royal London Hospital, London.