U.K's NICE Recommends BioCryst's Orladeyo To Prevent Attacks In HAE Patients

BioCryst Pharmaceuticals Inc. (BCRX) said that the United Kingdom's National Institute for Health and Care Excellence or NICE has recommended orladeyo (berotralstat) for preventing recurrent attacks of hereditary angioedema or HAE in eligible patients 12 years and older if they have at least two attacks per month.

HAE patients in England, Wales and Northern Ireland will have access to the first oral, once-daily therapy for routine prevention of recurrent HAE attacks.

The NICE recommendation was based on findings from the Phase 3 APeX-2 trial, in which orladeyo met its primary endpoint, significantly reducing HAE attacks vs placebo at 24 weeks. The reduction was sustained through 96 weeks, with an 80 percent average reduction in patients' mean attack rate per month during weeks 25-96 of the trial, compared to baseline.

The company noted that the positive NICE recommendation also expands access to modern prophylaxis with orladeyo, compared to the attack frequency requirements from NICE for injectable options.

The decision follows European Commission marketing authorization of orladeyo in April 2021 and approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in May 2021.

A decision from the Scottish Medicines Consortium (SMC) for use of ORLADEYO for HAE patients in Scotland under the UK's National Health Service (NHS) is anticipated in the first half of 2022.

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