The U.S. Food and Drug Administration (FDA) has agreed to review an application from Takeda to extend the approval of Takhzyro (lanadelumab) for children as young as 2 with hereditary angioedema (HAE). The application has been given priority review status and a decision from is expected in…
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The Phase 2 KOMPLETE clinical trial testing the ability of oral KVD824 to prevent attacks in people with hereditary angioedema (HAE) has been terminated. The decision by the therapy’s developer, KalVista Pharmaceuticals, was based on the observation of high levels of liver enzymes, a sign of inflammation…
A booster dose of Moderna’s COVID-19 vaccine is suspected of having caused acute attacks of acquired angioedema in an 86-year-old man, a case study reported. Its scientists stressed the importance of carefully examining patients set to undergo such vaccinations and considering rarer symptoms, noting this patient reported unusual upper-limb…
Japan’s Ministry of Health, Labour and Welfare has approved Berinert S.C. Injection 2000 — a C1-inhibitor replacement therapy designed to be self-administered at home via injection under the skin twice per week — for preventing swelling attacks in people with hereditary angioedema (HAE). The therapy has been approved in…
A splenic marginal zone lymphoma (SMZL) — a type of non-Hodgkin’s lymphoma that involves the spleen, bone marrow, and blood — might have triggered acquired angioedema in a man in his 60s, a case study reported. “The occurrence of [non-Hodgkin’s] lymphoma in association with [acquired…
Half the patients with hereditary angioedema (HAE) treated with Takhzyro (lanadelumab) for at least a year prolonged their dosing interval and used significantly less on-demand treatments, a real-world study found. Study findings were detailed in a clinical letter titled, “Real World treatment patterns of hereditary angioedema with…
A single infusion of the investigational gene therapy NTLA-2002 was well tolerated at two different doses and reduced the number of swelling attacks in people with hereditary angioedema (HAE) by more than 90%, according to interim results from the Phase 1 portion of a Phase 1/2 trial. The…
Atorvastatin, a cholesterol-lowering medication, has been linked to angioedema for the first time in a recent case report, highlighting the need for comprehensive evaluation of all medications taken by patients, regardless of their medical history. “Statins cannot be disregarded as the primary or contributing cause of angioedema,” researchers…
The European Patent Office has granted patent protection to Verseon covering the company’s experimental plasma kallikrein inhibitors (PKIs). Two of these investigational medications, called VE-4666 and VE-4062, are currently in preclinical development as potential treatments of hereditary angioedema (HAE). “We’re very pleased with the European Patent Office’s…
NTLA-2002, an experimental gene-editing therapy designed to prevent swelling attacks in people with hereditary angioedema (HAE), has been granted orphan drug status by the U.S. Food and Drug Administration (FDA). This designation is given to investigational treatments that have the potential to improve care for rare diseases, defined as…
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