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…
The first patient has been dosed in a Phase 3 clinical trial testing NTLA-2002, Intellia Therapeutics’ gene-editing treatment candidate for hereditary angioedema (HAE). The trial, called HAELO (NCT06634420), is expected to enroll an estimated 60 adults with HAE types 1 or 2; it’s recruiting participants at five…
Kalvista Pharmaceuticals has submitted an application asking Japan’s Ministry of Health, Labour and Welfare (MHLW) to approve its oral therapy sebetralstat as an on-demand treatment to manage swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. “The submission of our [new drug application] for sebetralstat…
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