News

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.

Sebetralstat up for approval in Japan as on-demand HAE 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…

Takhzyro effective in preventing HAE attacks: Real-world study

Takhzyro (lanadelumab), an injectable medication used to prevent hereditary angioedema (HAE) attacks, is highly effective at reducing the frequency of these episodes and increasing the proportion of patients who remain attack-free, a study into its real-world use reports. Researchers evaluated Takhzyro’s use in the clinic among HAE patients…