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Japan's Ministry of Health, Labour and Labour (MHLW) approved ORLADEYO (Berosty) for preventive treatment of hereditary angioedema

 Last Update: 2021-01-29
 Source: Internet
 Author: User

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Hereditary angioedema (HAE) is a disease characterized by recurrent angioedema, which is not accompanied by urticaria or itching and most commonly affects mucous membrane tissue in the skin or upper respiratory tract and gastrointestinal tract.
swelling is self-limiting and can subside within 2-5 days without treatment, throat damage can lead to fatal asphyxia.
pharmaceutical company BioCryst recently announced that Japan's Ministry of Health, Labour and Labour (MHLW) has approved ORLADEYO™ (Belostad) for the prevention of the sale and production of angioedema (HAE) in adults and children over 12 years of age.
ORLADEYO is the first and only preventive HAE drug approved in Japan.
orLADEYO capsule per day can prevent HAE attacks by reducing the activity of plasma kinetic peptide-releasing enzymes.
, a partner of BioCryst, will commercialize ORLADEYO in Japan.
will launch ORLADEYO in Japan after BioCryst successfully completed price negotiations with the NHS (NHI).
approval is based on data from clinical trials of APeX-J and APeX-2.
APeX-J trial in Japan reached its primary endpoint, with a significantly lower haE frequency in patients in the ORLADEYO group (p s 0.003) compared to placebo.
and ORLADEYO is safe and generally resistant in testing.

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