{"id":937706,"date":"2026-02-18T07:03:51","date_gmt":"2026-02-18T12:03:51","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/kalvista-pharmaceuticals-announces-inclusion-of-ekterly-sebetralstat-as-a-first-line-therapy-for-adolescents-12-and-older-in-international-pediatric-hae-guideline\/"},"modified":"2026-02-18T07:03:51","modified_gmt":"2026-02-18T12:03:51","slug":"kalvista-pharmaceuticals-announces-inclusion-of-ekterly-sebetralstat-as-a-first-line-therapy-for-adolescents-12-and-older-in-international-pediatric-hae-guideline","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/kalvista-pharmaceuticals-announces-inclusion-of-ekterly-sebetralstat-as-a-first-line-therapy-for-adolescents-12-and-older-in-international-pediatric-hae-guideline\/","title":{"rendered":"KalVista Pharmaceuticals Announces Inclusion of EKTERLY\u00ae (sebetralstat) as a First-Line Therapy for Adolescents 12 and Older in International Pediatric HAE Guideline"},"content":{"rendered":"

<\/p>\n

KalVista Pharmaceuticals Announces Inclusion of EKTERLY\u00ae (sebetralstat) as a First-Line Therapy for Adolescents 12 and Older in International Pediatric HAE Guideline<\/b><\/p>\n

Guideline recommends ensuring on-demand treatment is available anytime, anywhere and prioritizes early intervention and rapid self-administration, reinforcing the unique value of EKTERLY<\/i><\/p>\n

FRAMINGHAM, Mass. & SALISBURY, England–(BUSINESS WIRE<\/a>)–KalVista Pharmaceuticals<\/a>, Inc. (Nasdaq: KALV) today announced that the newly published International Guideline on the Diagnosis and Management of Pediatric Patients With Hereditary Angioedema recommends EKTERLY\u00ae (sebetralstat) as a first-line therapy for the acute treatment of hereditary angioedema (HAE) attacks in adolescents aged 12 years and older.1<\/sup><\/p>\n

\nBased on robust, high-quality evidence, including clinical trial data demonstrating consistent efficacy, rapid symptom relief and a favorable safety profile, the guideline committee issued a strong recommendation for the first-line use of sebetralstat in adolescents 12 and older with HAE. The recommendation comes just months after the launch of EKTERLY in the US and Germany and follows seven global regulatory approvals received in 2025. EKTERLY is the first and only oral on-demand treatment for people 12 and older with HAE.<\/p>\n

\n\u201cWe are encouraged to see this international guideline reflect the progress the HAE community has made toward more patient-centered care, particularly for adolescents,\u201d said Paul Audhya, MD, MBA, Chief Medical Officer of KalVista. \u201cThe first-line recommendation for EKTERLY so soon after becoming commercially available underscores the strength of our clinical data and reinforces the importance of ensuring patients have immediate access to effective on-demand therapy. As the first and only oral on-demand treatment for HAE, EKTERLY uniquely enables guideline-aligned care by supporting early intervention and simplifying self-administration, empowering adolescents 12 and older to treat at the earliest recognition of an attack.\u201d<\/p>\n

\nThe guideline emphasizes the importance of early intervention, noting that early treatment of attacks is associated with better outcomes and results in shorter, less severe episodes. However, real-world data show that adolescents with HAE have historically faced substantial delays administering treatment, waiting nearly eight hours on average to treat attacks due to the anxiety and challenges associated with injectable therapies.2<\/sup><\/p>\n

\nTo support early intervention, the guideline recommends ensuring pediatric patients have on-demand therapy available anytime, anywhere, consider treatment of all attacks, and have sufficient supply to treat at least two attacks, even when receiving long-term prophylaxis. In addition, it recommends having on-demand treatment available during potentially triggering events such as medical, dental and surgical procedures, while emphasizing that the activities and lifestyle of patients should be kept as normal as possible, provided they have rapid access to on-demand medication.<\/p>\n

\n\u201cWhile general protocols have existed for many years, these new recommendations recognize that children require care tailored to their unique needs to manage this rare and potentially life-threatening genetic condition,\u201d said Mauro Cancian, MD, PhD, Head of the Allergy Division at the University of Padua in Padova, Italy. \u201cHAE presents distinct physiological and psychological hurdles, particularly in adolescents, from puberty-driven flare-ups to the trauma of frequent injections. By moving beyond a ‘one-size-fits-all’ approach, the guidelines provide a clear framework for care that supports not only rapid life-saving treatment, but also a child\u2019s long-term health and emotional well-being.\u201d<\/p>\n

\nEKTERLY is currently approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of HAE in people 12 years of age and older. It is marketed in the US and Germany, with additional global launches anticipated in 2026 and beyond. KalVista continues to advance the KONFIDENT-KID trial\u2014the fastest-enrolling pediatric HAE trial conducted to date\u2014and is on track to submit a new drug application for sebetralstat in patients aged 2 to 11 in the third quarter of 2026.<\/p>\n

\nDeveloped by an International Steering Committee, Taskforce and the Hereditary Angioedema Working (HAWK) Group, the guideline was published in Allergy<\/i>, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI).<\/p>\n

About Hereditary Angioedema
\n
<\/b>Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity.<\/p>\n

About KONFIDENT-KID
\n
<\/b>KONFIDENT-KID is an open label clinical trial of sebetralstat for on-demand treatment of HAE attacks in pediatric patients. Originally designed to enroll 24 pediatric patients, the trial was met with high demand and will ultimately enroll approximately 36 children aged two to 11 years across seven countries in North America, Europe and Asia. KONFIDENT-KID will collect safety, pharmacokinetic and efficacy data for each patient for up to one year and features a proprietary pediatric oral disintegrating tablet (ODT) formulation of sebetralstat. If approved, sebetralstat would be the first oral on-demand therapy for this age group, and only the second FDA-approved on-demand therapy of any type for this population.<\/p>\n

About KalVista Pharmaceuticals, Inc.
\n
<\/b>KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY\u00ae\u2014the first and only oral on-demand treatment for hereditary angioedema (HAE)\u2014and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com<\/a> and follow us on LinkedIn<\/a>, X<\/a>, Facebook<\/a> and Instagram<\/a>.<\/p>\n

INDICATION AND IMPORTANT SAFETY INFORMATION
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<\/b>What is EKTERLY\u00ae (sebetralstat)?
\n
<\/b>EKTERLY is a prescription medicine used to treat sudden (acute) attacks of hereditary angioedema (HAE) in adults and children aged 12 years of age and older. It is not known if EKTERLY is safe and effective in children under 12 years of age.<\/p>\n

IMPORTANT SAFETY INFORMATION<\/b><\/p>\n

Before taking EKTERLY, tell your healthcare provider about all of your medical conditions, including if you:<\/b><\/p>\n