贝罗司他胶囊可是预防遗传性血管性水肿发作的药物

Capsules may prevent hereditary angioedema attacks

Berosostat capsule is a plasma kallikrein inhibitor that binds to plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high molecular weight kininogen (HMWK) to produce cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability, leading to the swelling and pain associated with HAE. In patients with HAE due to C1 deficiency or dysfunction of the inhibitor (C1-INH), plasma kallikrein activity is not regulated normally, which leads to an uncontrolled increase in plasma kallikrein activity and leads to angioedema attack. Berosostat capsules reduce plasma kallikrein activity to control excessive bradykinin production in hospitalized patients with HAE.

Hereditary angioedema (HAE) is a disease characterized by recurrent episodes of angioedema without urticaria or pruritus, most commonly involving the skin or mucosal tissues of the upper respiratory tract and gastrointestinal tract. Although the swelling is self-limiting and resolves within 2-5 days without treatment, laryngeal involvement may lead to fatal suffocation; in 2021, the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the sales and production license of Berostat for the prevention of angioedema (HAE) in adults and children over 12 years old.

Berosostat capsules are the first and only preventive HAE drug approved in Japan. One capsule of berosostat per day can prevent the onset of HAE by reducing the activity of plasma kallikrein.

The approval was based on data from the APeX-J and APeX-2 clinical trials. Japan's APeX-J trial met its primary endpoint, with patients receiving berosostat capsules experiencing a significant reduction in the frequency of HAE attacks compared with placebo (p = 0.003). Moreover, berosostat capsules are safe and generally tolerated in trials.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

Recommended related articles: