Ekterly (sebetralstat)
Ekterly was approved for the treatment of hereditary angioedema (HAE) attacks caused by C1 inhibitor deficiency or dysfunction, in patients aged 12 years and older. Ekterly contains the active ingredient sebetralstat.
Ekterly is a medicine approved to treat sudden swelling attacks in people with hereditary angioedema (HAE).
Hereditary angioedema is a rare genetic condition that causes unpredictable and sometimes dangerous swelling in areas like the skin, face, stomach, and airways. These attacks can happen without warning and may be triggered by things like stress, injury, infection, or certain medications.
Ekterly is for people aged 12 years and older who have HAE caused by a deficiency in a protein called C1 inhibitor.
People with HAE have a shortage or malfunction of their C1 inhibitor protein (also known as C1-INH). C1-INH is a natural protein found in your blood. Its main role is to help control inflammation and prevent swelling by keeping certain parts of the immune system in check.
Without enough C1-INH or if it doesn’t work properly, the body makes too much bradykinin, a substance that causes blood vessels to leak fluid and results in swelling.
Ekterly is a tablet that is taken when an attack starts and helps to quickly reduce symptoms by blocking the effects of bradykinin. This makes the attack resolve faster.
Ekterly was tested in a large clinical study with 136 patients who were 12 years or older. The study compared Ekterly to a placebo (treatment with no active medicine) and looked at how quickly people felt better after taking the medicine. The main goal was to see how long it took for patients to feel ‘a little better’ after starting treatment.
The study showed that patients felt relief faster with Ekterly treatment compared to patients taking the placebo.
Key findings from the clinical study
- People taking Ekterly felt relief much faster than those taking the placebo – around 1.6 hours to 1.8 hours compared to 6.7 hours for the placebo.
- Ekterly was generally well tolerated.
- The most common side effects were mild headaches, but these were not serious and only affected a few people. For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document (found below).
In the event of a laryngeal attack, medical attention should be sought immediately due to the potential seriousness of this type of attack.
The TGA decided that the application has provided sufficient evidence supporting the safety and effectiveness of Ekterly and the medicine can be registered for use in Australia.
More detailed information on why the TGA approved Ekterly will be published in the upcoming Australian Public Assessment Report (AusPAR).
The information in this decision summary will not be updated to include any subsequent changes, so may not represent the most current information for a medicine. For current information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs for Ekterly can be accessed through the ARTG hyperlinks provided below.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs for Ekterly can be accessed through the ARTG hyperlinks provided below
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.