- As CSL's first monoclonal antibody discovered and developed in-house by CSL scientists, ANDEMBRY® will be available on the Pharmaceutical Benefits Scheme from April 1, 2026.
- ANDEMBRY® is a once-monthly treatment targeting activated factor XII (FXIIa) to prevent recurrent attacks of unpredictable swelling in people living with hereditary angioedema (HAE).1
- The launch of ANDEMBRY® expands CSL's HAE franchise and underscores the company's commitment to delivering innovative medicines to the HAE community.
[Melbourne, Australia – April 1, 2026] – Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) is pleased to announce that from April 1, 2026, ANDEMBRY® (garadacimab) will be available on the Pharmaceutical Benefits Scheme (PBS) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in eligible patients with C1-INH HAE (C1-esterase inhibitor deficiency or dysfunction).1,2
This new PBS listing is based on their evaluation of the pivotal international Phase 3 VANGUARD trial and its open-label extension study.3,4
HAE is a rare, chronic, and potentially life-threatening genetic disorder characterised by recurrent and unpredictable attacks of swelling.5,6 Attacks of HAE are often painful and can affect multiple sites of the body, including the abdomen, larynx, face, and extremities.6,7
ANDEMBRY® is a once-monthly treatment targeting activated factor XII (FXIIa), a plasma protein that initiates the cascade of events leading to attacks of swelling in people living with HAE.1,7 ANDEMBRY® is available in a pre-filled pen for subcutaneous self-injection by patients or caregivers.1 ANDEMBRY® should be initiated under the supervision of a healthcare professional experienced in the management of HAE.1
The therapy was discovered and optimised at CSL's Melbourne research laboratories, with formulation and clinical manufacturing completed at the Broadmeadows Biotech Manufacturing Facility in Victoria. The launch of ANDEMBRY® reinforces CSL's decades-long commitment to developing and delivering innovative therapies for the HAE community.
"ANDEMBRY targets factor XIIa, an enzyme known to start the cascade that leads to hereditary angioedema," said Professor Connie Katelaris AM, treating physician and study investigator for the VANGUARD open-label extension. "This mechanism gives us an additional preventive option supported by peer-reviewed clinical evidence."
Fiona Wardman, Director of HAE Australasia, a patient advisory group supporting people with HAE in Australia and New Zealand welcomed the decision.
"For people living with HAE, access to a range of funded treatment options is important," said Fiona Wardman. "Unpredictable swelling attacks can affect daily activities and overall wellbeing. The PBS listing of ANDEMBRY adds another funded option for eligible Australians, supporting treatment decisions made between patients and their healthcare professionals."
"ANDEMBRY represents Australian innovation at its best, having been discovered in our Melbourne research laboratories and manufactured in Victoria," said Danielle Dowell, Executive Director, General Manager, CSL Australia and New Zealand. "We welcome its PBS listing and remain committed to supporting the HAE community and partnering with clinicians, government and patient organisations to enable timely access to innovative therapies."
The launch of ANDEMBRY® expands CSL's HAE franchise and enhances the company's ability to meet the evolving needs of patients.
About HAE
HAE is a rare, chronic, debilitating, and potentially life-threatening genetic disease that occurs in about 1 in 50,000 people.5,6 It is characterised by recurrent and unpredictable attacks of swelling that are often painful and can occur in multiple sites of the body, including the abdomen, larynx, face, and extremities.5,6 HAE is most frequently caused by deficient or dysfunctional C1-INH, a protein in the blood that helps to control inflammation.6,7 Inadequate amounts of properly functioning C1-INH can lead to increased vascular permeability, causing subsequent swelling referred to as angioedema.6,7 HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if left untreated, death.6,7
About ANDEMBRY® (garadacimab)
ANDEMBRY® (garadacimab) is a Factor XIIa-inhibitory monoclonal antibody (anti-FXIIa mAb) that has achieved regulatory approval as a once-monthly subcutaneous preventative treatment for HAE attacks.1,3,4 ANDEMBRY® is indicated for routine prevention of recurrent HAE attacks in patients aged 12 years and older with C1-INH HAE (C1-esterase inhibitor deficiency or dysfunction), and is now accessible via the PBS for eligible patients.8 ANDEMBRY® is CSL's first recombinant monoclonal antibody to gain approval and was discovered and developed entirely by CSL scientists. ANDEMBRY® inhibits FXIIa, the activated form of the plasma protein FXII.1 FXIIa initiates the cascade of events leading to attacks of swelling in people living with HAE. By targeting FXIIa, ANDEMBRY® inhibits this cascade at the top.
How to use: ANDEMBRY® should be initiated under the supervision of a healthcare professional experienced in the management of patients with HAE. ANDEMBRY® may be self-administered or administered by a caregiver only after receiving training on the subcutaneous injection technique by a healthcare professional.1 ANDEMBRY® is not intended for the treatment of acute HAE attacks.3
Warnings:1 Do not use ANDEMBRY® if you are allergic to garadacimab, or to any of the excipients. Always check the ingredients to make sure you can use this medicine. All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects can be serious and may include hives, tightness of the chest, difficulty breathing, wheezing, hypotension, and/or anaphylaxis. Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice this serious side effect.
Precautions:1 Patients should inform their doctor if they are pregnant or intend to become pregnant or are breastfeeding or intend to breastfeed.
Interactions:1 Patients should inform their doctor if they are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Side effects:1 The most common side effects with ANDEMBRY® are reactions at the injection site, including redness, bruising and itchiness. A possible serious side effect with ANDEMBRY® is allergic reactions. Call your doctor straight away or go to the Emergency Department at your nearest hospital if you have a severe allergic reaction to ANDEMBRY® with symptoms such as hives, tight chest, low blood pressure (such as feeling dizzy or light headed), or signs of anaphylaxis such as difficulty breathing or wheezing.
