Key Summary
- MHRA approves Ekterly as the first oral treatment for HAE in patients aged 12 and older
- It works by blocking bradykinin, which causes painful swelling
- Common side effects include headache, with full details on the MHRA website
The Medicines and Healthcare products Regulatory Agency (MHRA) approved sebetralstat (Ekterly), an oral treatment for hereditary angioedema (HAE) in adults and adolescents aged 12 years and above.
HAE is a rare genetic condition that can cause sudden and painful swelling in various parts of the body, including the face, throat, abdomen, and limbs.
Attacks can be unpredictable and, in some cases, life-threatening if they affect the airways.
Sebetralstat (Ekterly) was approved in the KONFIDENT clinical trial, in which 110 patients took part.
Ekterly is the first ever oral, on-demand treatment approved by MHRA.
The medication blocks the release of a substance called bradykinin, which leaks fluid in blood vessels leading to swelling.
The patients are suggested to consume the tablet immediately when the symptoms manifest.
“Patient safety is our top priority, which is why we are pleased to approve sebetralstat for the treatment of hereditary angioedema attacks (HAE),” said Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access.
Beach added that MHRA will continue to monitor the drug’s safety.
However, Ekterly is prone to side effects including headache, dyspepsia, nausea, abdominal pain, fatigue, back pain and hot flushes.
A full list of side effects will soon be available on the MHRA website
