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.
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…
Intellia Therapeutics is planning to submit an application requesting the approval of NTLA-2002, its gene-editing therapy for hereditary angioedema (HAE), to U.S. regulators in late 2026. The company recently announced it would be discontinuing programs for other diseases, as well as reducing its workforce, to focus efforts…
A European Medicines Agency (EMA) committee has recommended that the antibody-based therapy garadacimab be approved as a once-monthly preventive treatment to reduce the risk of swelling attacks in people with hereditary angioedema (HAE) ages 12 and older. The positive opinion from the EMA’s Committee for Medicinal Products…
There are notable differences between hereditary angioedema with normal C1-inhibitor function (HAE nC1-INH) and idiopathic angioedema of unknown etiology (AE-UNK), even though they share many features, a real-world Canadian study indicates. Some of the differences include the time to reach a diagnosis, attack triggers and characteristics, and treatment…
Theratechnologies said it will ask Health Canada next year to approve donidalorsen, an experimental injection therapy designed to reduce the risk of swelling attacks in people with hereditary angioedema (HAE). The company agreed to acquire exclusive rights to commercialize the treatment in the country. Donidalorsen, originally developed…
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