Sebetralstat, an oral small molecule being developed by Kalvista Pharmaceuticals, provided adults and adolescents with hereditary angioedema (HAE) with early on-demand treatment for swelling attacks and offered fast symptom relief, even when swelling affected the larynx (voice box). That’s according to interim data from KONFIDENT-S (NCT05505916),…
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…
An oral granule formulation of Orladeyo (berotralstat) was safe and well tolerated, and able to reduce the rates of swelling attacks in children with hereditary angioedema (HAE), according to an interim analysis of an ongoing Phase 3 trial. The open-label Phase 3 APeX-P trial (NCT05453968) is assessing the…
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 European Commission has approved Andembry (garadacimab) as a monthly treatment for preventing swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. The decision, which is consistent with a recommendation issued by a European Medicines Agency committee last year, is valid in all countries…
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.
An assay that measures C1 inhibitor (C1-INH) activity on a dried blood spot after a blood sample is blotted onto a piece of filter paper appears to work as well as a standard, color-based assay to diagnose hereditary angioedema (HAE) and is easier to handle, a study found. Dried…
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