This national approval has been granted through an ACCESS work-sharing procedure. The ACCESS consortium is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements.
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.
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.
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 the full list of all side effects reported with this medicine, see Section 4 of the Patient Information leaflet or the Summary of Product Characteristics available 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.
ENDS
Notes to editors
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The new marketing authorisation was granted on January 24th 2025 to CSL Behring GmbH
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This product was submitted and approved via a national procedure and ACCESS.
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the [email protected], or call on 020 3080 7651.
