Biocryst Pharmaceuticals has submitted an application asking the U.S. Food and Drug Administration (FDA) to extend the approval of Orladeyo (berotralstat) to children with hereditary angioedema (HAE) as young as 2 years. The application specifically seeks the approval of an oral granule formulation of the therapy for…
More than 90% of people with hereditary angioedema (HAE) are interested in trying new prophylactic (preventive) treatments, according to a recent poll. The survey also highlighted disconnections between patients and clinicians, and their impressions of how well the disease is being managed. The poll surveyed 150 adults living…
A simple diagnostic score may help distinguish between two types of angioedema — mast cell-mediated angioedema and drug-induced nonallergic angioedema — in people taking angiotensin-converting enzyme (ACE) inhibitors, researchers said. They described the scoring system in the study, “Angiotensin-converting enzyme inhibitor-induced angioedema: Proposal for a diagnostic…
Short-term preventive treatment before dental procedures may not be necessary for people with hereditary angioedema (HAE) who are already on long-term prophylaxis, according to a new study by researchers in Germany. It’s well-established that dental procedures and surgeries can act as triggers to increase the risk of the swelling…
Astria Therapeutics has initiated a Phase 3 clinical trial to study its experimental therapy navenibart in adults and adolescents with hereditary angioedema (HAE). The study, called ALPHA-ORBIT (NCT06842823), is planned to be pivotal, meaning, if the results are positive, the trial may serve as the basis to…
Andembry (garadacimab) is approved in Switzerland as a prophylactic (preventive) treatment to lower the frequency of recurrent swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. The decision by the Swiss Agency for Therapeutic Products marks the fifth regulatory approval of Andembry for HAE, following…
The European Medicines Agency (EMA) has approved a new pre-filled pen version of Takhzyro (lanadelumab) as a treatment for people, 12 and older, with hereditary angioedema (HAE), according to an announcement from Takeda, the company that markets Takhzyro. The new pen option contains 300 mg of lanadelumab,…
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Andembry (garadacimab) as a treatment to reduce the risk of swelling attacks in people with hereditary angioedema (HAE). The approval makes Andembry the first long-term preventive treatment in Japan available in a prefilled pen and given once…
On-demand treatment with oral sebetralstat is effective for controlling swelling attacks in people with hereditary angioedema (HAE) who are on long-term preventive treatment, an interim analysis from a clinical trial shows. The findings were presented this month at the Western Society of Allergy, Asthma and Immunology (WSAAI) 2025…
The government agency in Portugal that regulates human medicines, Infarmed, has recommended Orladeyo (berotralstat) for the routine prevention of swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. With this positive recommendation, HAE patients in the country will now be able to access Orladeyo treatment.
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