CSL's ANDEMBRY® Receives European Commission Approval
CSL's ANDEMBRY® Approval by the European Commission
The European Commission has officially approved ANDEMBRY® (garadacimab) as a groundbreaking treatment for patients suffering from hereditary angioedema (HAE). This treatment is notable for being the only once-monthly therapy targeting factor XIIa, a pivotal protein in the angioedema process. ANDEMBRY works by inhibiting factor XIIa, thus interrupting the cascade that leads to the painful swelling associated with HAE.
Significance of ANDEMBRY in HAE Management
With the approval of ANDEMBRY, CSL reaffirms its long-standing commitment to innovating therapies for the HAE community. The treatment features a user-friendly pre-filled pen, allowing for convenient subcutaneous self-administration by patients, which greatly enhances their experience and adherence to treatment protocols.
Clinical Trials and Approval Process
The efficacy and safety of ANDEMBRY are substantiated by robust data from the Phase 3 VANGUARD trial. This clinical study underscored the treatment’s promising results and safety profile, leading to its recent approvals not only in Europe but also in Australia and the UK.
Understanding Hereditary Angioedema and Its Impact
Hereditary angioedema is a rare yet severe genetic disorder that can cause unpredictable, painful swellings in various parts of the body, including the abdomen and throat. It affects approximately 1 in 50,000 individuals, presenting significant life disruptions. Patients often endure a heavy physical and emotional burden due to the unpredictable nature of HAE attacks.
Integration of Clinical Insights
Leading experts in the field, like Dr. Markus Magerl from Charité University Hospital Berlin, highlight that the true prevalence of HAE might be underestimated due to frequent misdiagnoses in patients. By utilizing ANDEMBRY, healthcare providers now have a new option that acts at the initial stage of the angioedema cascade, offering patients a reliable preventive method against attacks.
Future Prospects for ANDEMBRY
Following this significant milestone, ANDEMBRY is set to be available for eligible patients once the access and reimbursement negotiations are finalized. The centralized marketing authorization means that ANDEMBRY can be distributed across all European Union member states and the European Economic Area.
About ANDEMBRY
ANDEMBRY represents the first recombinant monoclonal antibody entirely developed by CSL. The innovative therapy was discovered and optimized at CSL’s Biotech Manufacturing Facility, showcasing the company’s dedication to solving unmet medical needs through scientific research. ANDEMBRY is unique in its mechanism, targeting factor XIIa to effectively prevent the onset of edema.
Ongoing Development and Regulatory Review
Simultaneously, ANDEMBRY's review continues in several significant markets, including the United States, Japan, Switzerland, and Canada, which could expand access for more patients worldwide as regulatory decisions are made.
CSL's Commitment to Patients
CSL, a globally recognized biotechnology firm, has an impressive history of developing lifesaving medicines. With its expansive portfolio including treatments for hemophilia, immune deficiencies, and vaccines, CSL remains committed to enhancing the quality of life for patients around the world. Their focus on research and development continues to drive innovations like ANDEMBRY, making a real difference in patient care.
Frequently Asked Questions
What is ANDEMBRY used for?
ANDEMBRY is used to prevent recurrent attacks of hereditary angioedema in patients aged 12 and older.
How does ANDEMBRY work?
It inhibits the factor XIIa protein, preventing the cascade of events that lead to angioedema.
What are the side effects of ANDEMBRY?
Common side effects include injection site reactions, such as redness and bruising.
Is ANDEMBRY available worldwide?
While it has received approval in the EU and other regions, it is still under review in several countries including the U.S. and Japan.
Who developed ANDEMBRY?
ANDEMBRY was discovered and developed entirely by CSL's research teams.
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