The Medicines and Healthcare products Regulatory Agency (MHRA) have approved garadacimab (brand name Andembry) for patients aged 12 and over with hereditary angioedema (HAE) to prevent angioedema attacks. HAE is a rare condition that causes fluid to build up in the body, and triggers sudden and repeated swelling. It often runs in families.

The newly approved drug, garadacimab, is administered as an under-the-skin injection. Following a study undertaken with 64 adult and paediatrics patients with HAE, the study showed that over six months of treatment, those who had taken the drug had a lower monthly rate of HAE attacks compared with patients given the placebo.

Julian Beach, MHRA interim executive director of Healthcare Quality and Access, said: “Patient safety is our top priority, which is why I am pleased to confirm approval of garadacimab for patients with hereditary angioedema to prevent angioedema attacks.

“We’re assured that the appropriate regulatory standards of safety, quality, and efficacy for the approval of this new medicine have been met.

“As with all products, we will keep its safety under close review.”