BioCryst’s Orladeyo (berotralstat) has received a positive recommendation from the National Institute for Health and Care Excellence (NICE) for preventing recurrent attacks of hereditary angioedema (HAE) in people aged 12 years and older.

In its draft guidance, NICE has recommended the treatment for people who have at least two attacks per month. Orladeyo treatment should be stopped if the number of attacks per month does not reduce by at least 50% after three months of use.

HAE affects around one person per 50,000 to 100,000, and is characterised as a rare genetic disorder.

People living with this condition experience unpredictable and recurrent attacks of swelling in the mouth, gut or airway. In turn, this can lead to breathing difficulties and severe pain and can also cause swelling in multiple body parts.

Clinical trial evidence for Orladeyo suggests that the treatment reduces the frequency of swelling attacks, although the effect on the severity of these attacks is ‘uncertain’, according to NICE.

“We are excited for HAE patients that this recommendation from NICE provides access to the first oral, once-daily treatment for UK patients to achieve symptom control and experience relief from the burdens of HAE,” said Charlie Gayer, chief commercial officer of BioCryst.

“The positive NICE recommendation also expands access to modern prophylaxis with Orladeyo, compared to the attack frequency requirements from NICE for injectable options,” he added.