MHRA Grants Approval for Garadacimab to Prevent Angioedema Attacks
On 24 January 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) approved garadacimab, marketed under the brand name Andembry, for patients aged 12 years and older with hereditary angioedema (HAE).
This national approval marks a significant advancement in the prevention of angioedema attacks, providing new hope for individuals affected by this rare and often debilitating condition.
The approval was granted through an Access Consortium work-sharing procedure. The Access Consortium, a medium-sized coalition of regulatory authorities, facilitates collaboration and alignment of regulatory requirements to ensure efficient approval processes.
This regulatory milestone underscores the growing emphasis on international cooperation in bringing innovative treatments to patients.
HAE is a rare genetic disorder that causes unpredictable and potentially life-threatening swelling in various parts of the body. These attacks result from a buildup of fluid and can affect the face, limbs, airways, and internal organs.
While hereditary in nature, some individuals may develop HAE without a prior family history, making early diagnosis and preventive treatment crucial.
Garadacimab is a subcutaneous (under the skin) injection designed to reduce the frequency of angioedema attacks in HAE patients. A clinical study involving 64 adult and paediatric patients with a history of at least two angioedema attacks within a two-month run-in period demonstrated promising results.
Over a six-month treatment duration, patients receiving garadacimab exhibited a lower monthly rate of attacks compared to those given a placebo. Additionally, a greater proportion of patients on garadacimab remained attack-free during the first three months of treatment.
In response to the approval, the MHRA’s Interim Executive Director of Healthcare Quality and Access emphasised the agency’s commitment to patient safety.
They stated that ensuring the safety and well-being of patients is their top priority. Furthermore, they added that they are pleased to confirm the approval of garadacimab for hereditary angioedema, providing an important new option to prevent attacks.
Also, they are confident that the appropriate regulatory standards of safety, quality, and efficacy have been met, and the MHRA assured that, as with all newly approved treatments, garadacimab’s safety will be closely monitored.
In conclusion, the approval of garadacimab represents a major advancement for those living with hereditary angioedema. By reducing the frequency and severity of angioedema attacks, this treatment has the potential to improve the quality of life for patients who have long struggled with the unpredictability of their condition.
With continued regulatory oversight and further research, this new medicine stands as a beacon of hope in the evolving landscape of rare disease treatments.
News Credits: Garadacimab (andembry) approved to prevent angioedema attacks
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