Andembry (garadacimab), a first-in-class treatment to prevent swelling attacks in people with hereditary angioedema (HAE), ages 12 and older, is now available in Japan. The treatment was approved by Japan’s Ministry of Health, Labour and Welfare in February, Andembry is the first prophylactic (preventive) therapy in Japan that…

Kaken Pharmaceutical obtained the rights to commercialize sebetralstat, an on-demand treatment for hereditary angioedema (HAE), in Japan under a licensing agreement with the HAE treatment’s developer, Kalvista Pharmaceuticals. Under the terms of the agreement, Kalvista will be eligible to receive an upfront payment of $11 million,…

Takhzyro (lanadelumab) has been approved in Japan to prevent acute swelling attacks in people, 12 and older, with hereditary angioedema (HAE). An estimated 2,000 to 3,000 people with HAE live in Japan, but fewer than 500 have been diagnosed due to a lack of awareness, according to…

Japanese researchers have identified a new mutation in the SERPING1 gene linked to hereditary angioedema (HAE) in a 27-year-old woman with a history of recurrent swelling attacks. Her case was described in a report, “Hereditary angioedema with a novel mutation, c.1481G>C, in the SERPING1 gene,” published…

Japan’s National Health Insurance System (NHI) has approved the addition of Orladeyo (berotralstat), an oral preventive treatment for hereditary angioedema (HAE) attacks, to its drug price list. This means that the NHI will reimburse hospitals and pharmacies prescribing Orladeyo to a certain amount under national health insurance programs.

Takeda has submitted an application in Japan seeking regulatory approval of Takhzyro (lanadelumab) for the treatment of hereditary angioedema (HAE). The company’s new drug application to the Japanese Ministry of Health, Labour and Welfare (MHLW) specifically asks Takhzyro be approved for the prophylactic, or preventive, treatment of…

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved oral Orladeyo (berotralstat), at a daily dose of 150 mg, to prevent hereditary angioedema (HAE) attacks in individuals ages 12 and up. According to the therapy’s developer, BioCryst Pharmaceuticals, Orladeyo is the first prophylactic, or preventive, HAE medication approved…

BioCryst Pharmaceuticals is prepared to launch Orladeyo (berotralstat), an oral treatment for hereditary angioedema (HAE), by the end of the year if the medication is approved, the company has announced. “We are currently in an exciting transformation from a company primarily focused on R&D [research and development]…

BioCryst Pharmaceuticals has submitted an application to the Japanese regulatory authority asking that oral berotralstat (BCX7353) be approved for the prevention of swelling attacks in people with hereditary angioedema (HAE). The new drug application (NDA), submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, follows…

BioCryst Pharmaceuticals has licensed rights to Torii Pharmaceutical for the commercialization of BCX7353 — an oral, once-daily investigational therapy for the prevention of hereditary angioedema (HAE) attacks — in Japan, pending the treatment’s approval. The plan is for BioCryst to submit a Japanese new drug application (JNDA)…