News

Sebetralstat provides early, fast relief for HAE attacks: Data

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),…

Pivotal Phase 3 clinical trial of navenibart in HAE launched

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…

Pre-filled pen version of Takhzyro approved in Europe

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,…

Andembry approved in Japan as preventive treatment for HAE

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…

Sebetralstat controls swelling in long-term prophylaxis patients

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…

European regulators approve garadacimab as Andembry for HAE

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…

Oral HAE treatment Orladeyo now available to patients in Portugal

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.