The Medicines and Healthcare products Regulatory Agency (MHRA) has approved KalVista Pharmaceuticals’ Ekterly (sebetralstat) to treat hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older.
The decision makes Ekterly the first and only oral on-demand treatment for HAE to be approved by the UK regulator, offering patients the ability to treat the attacks as soon as they start, wherever they are, without the need for injections.
HAE is a rare and potentially life-threatening genetic condition that causes fluid to build up throughout the body, including the face, throat, abdomen and limbs, triggering recurrent and unpredictable attacks of painful swelling.
Taken at the earliest sign of an attack, KalVista’s Ekterly is designed to prevent the release of a substance in the body called bradykinin, which causes blood vessels to leak fluid.
The approval was supported by results from the late-stage KONFIDENT trial, which showed that Ekterly significantly reduced the time from attack to beginning of symptom relief and full attack resolution compared to placebo.
Ekterly will also be added to the MHRA’s Orphan Register, allowing it to benefit from up to ten years of market exclusivity.
Julian Beach, MHRA interim executive director of healthcare quality and access, said: “HAE attacks can have a sudden and serious impact on people’s lives, often requiring immediate intervention.
“This approval is the first and only MHRA-approved oral option for treating HAE attacks, which will be valuable for patients who prefer not to use injectable treatments.”
The drug was granted a positive scientific opinion for an Early Access to Medicines Scheme by the MHRA in March, allowing it to be prescribed by healthcare professionals prior to receiving UK marketing authorisation.
It will continue to be available through the scheme until KalVista receives a decision from the National Institute for Health and Care Excellence for use under the NHS, expected in the first half of next year.
KalVista’s chief executive officer, Ben Palleiko, said: “This approval holds particular significance for KalVista as Ekterly was discovered in our Salisbury, UK labs – making it even more exciting that now we will be able to offer this therapy to people living with HAE in the UK.”
