A European Medicines Agency (EMA) committee recommended that Dawnzera (donidalorsen) be approved to prevent swelling attacks in hereditary angioedema (HAE) patients 12 and older. The positive opinion comes from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which is tasked with reviewing safety and efficacy data…
For most people with hereditary angioedema (HAE) given on-demand treatment in clinical trials with the now-approved therapy Ekterly (sebetralstat), swelling attacks stopped getting worse within 20 minutes of the oral medication being administered. That’s according to new data that Kalvista Pharmaceuticals, Ekterly’s developer, shared earlier this month…
Biocryst Pharmaceuticals has sold the European rights to Orladeyo (berotralstat), its approved oral therapy for preventing swelling attacks in people with hereditary angioedema (HAE), to the Italian pharmaceutical company Neopharmed Gentili. Under the terms of the deal, according to a Biocryst press release, the company “will…
Ekterly (sebetralstat) is now approved by both the European Commission and Swissmedic as an on-demand treatment to manage swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. These new approvals, which come on the heels of similar approvals in the U.S. and the…
A monthly injection therapy developed by CSL Behring has won approval from Health Canada to prevent swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. The approval of Andembry (garadacimab-gxii) follows approvals this year in the U.S., the European Union, the…
Kaken Pharmaceutical has secured the rights to develop and commercialize navenibart, an investigational treatment for hereditary angioedema (HAE), in Japan. Kaken will pay $16 million as part of an agreement with navenibart developer Astria Therapeutics that includes another $16 million if development and sales milestones are…
People with hereditary angioedema (HAE) types 1 and 2 had fewer swelling attacks and reported improvements in quality of life after they switched to donidalorsen from other preventive therapies, according to interim data from an ongoing clinical trial. “The study was designed to provide patients and physicians with…
In the years following treatment with the gene-editing therapy lonvoguran ziclumeran, or lonvo-z — also known as NTLA-2002 — most people with hereditary angioedema (HAE) taking part in a clinical trial have been completely free from swelling attacks without the need for long-term preventive therapy. That’s according to…
The use of Orladeyo (berotralstat) — widely approved as a preventive treatment for hereditary angioedema (HAE) — can help reduce the rates of swelling attacks in people with HAE of different ages, according to new data from clinical trials and real-world analyses. Biocryst Pharmaceuticals, the developer of the…
Treatment with the daily oral therapy Orladeyo (berotralstat) can effectively reduce swelling attack rates in people with hereditary angioedema (HAE) who experienced many such attacks before starting on the therapy, real-world data showed. Additional real-world data indicated that Orladeyo is also effective for preventing swelling attacks in adolescents…
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