The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved garadacimab (brand name Andembry) for the prevention of angioedema attacks in individuals aged 12 and up with hereditary angioedema (HAE). This national approval was given through the Access Consortium's work-sharing method. The Access consortium is a medium-sized coalition of regulatory bodies working to foster improved regulatory coordination and regulatory requirement alignment.

HAE is a rare condition that causes fluid to build up throughout the body, triggering sudden and repeated serious swelling. HAE is a condition that often runs in families, but some people may not have a family history.

Garadacimab is administered as a subcutaneous (under the skin) injection. A study was undertaken with patients involving 64 adult and paediatric patients with HAE, who experienced at least who experienced at least 2 attacks during the run-in period, which lasted up to 2 months. The study showed that over six months of treatment, patients taking garadacimab had a lower monthly rate of HAE attacks compared with patients given placebo. Additionally, more patients taking garadacimab were attack-free during the first 3 months of treatment compared to placebo.

For a complete list of all side effects documented with this medicine, see Section 4 of the Patient Information leaflet or the Summary of Product Characteristics on the MHRA website.

Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.  

Learn more: Garadacimab (andembry) approved to prevent angioedema attacks - GOV.UK