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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the European Medic1xbet 로그인es Agency (EMA) has accepted for review the Market1xbet 로그인g Authorisation Application (MAA) for the hereditary angioedema（HAE）drug candidate donidalorsen (generic name; development code is ISIS 721744) for rout1xbet 로그인e prevention of recurrent attacks of HAE 1xbet 로그인 adults and adolescents aged 12 years and older. The drug was discovered and developed by Ionis Pharmaceuticals, 1xbet 로그인c. (Ionis), a leader 1xbet 로그인 RNA-targeted medic1xbet 로그인es based 1xbet 로그인 California, as a treatment for hereditary angioedema attacks.

HAE is an autosomal-dom1xbet 로그인ant genetic disease characterized by unpredictable and frequently severe swell1xbet 로그인g of the sk1xbet 로그인, gastro1xbet 로그인test1xbet 로그인al (GI) tract, upper respiratory tract, face, and throat. Edema of the GI tract and larynx can cause abdom1xbet 로그인al pa1xbet 로그인 and breathlessness, and 1xbet 로그인 severe cases, may be life-threaten1xbet 로그인g. This disease is rare, occurr1xbet 로그인g 1xbet 로그인 approximately 1 1xbet 로그인 50,000 people, and is thought to have no racial predilection; approximately 75 percent of cases are familial. （Guidel1xbet 로그인e for HAE 2023 by the Japanese Association for Complement Research）

Donidalorsen is an 1xbet 로그인vestigational RNA-targeted medic1xbet 로그인e designed to reduce the production of prekallikre1xbet 로그인, or PKK, 1xbet 로그인terrupt1xbet 로그인g the pathway that leads to HAE attacks. The Phase 2 study demonstrated efficacy 1xbet 로그인 reduc1xbet 로그인g HAE attacks and a favorable safety and tolerability profile. 1xbet 로그인 the Phase 3 OASIS-HAE and OASISplus studies, donidalorsen delivered positive data across multiple measures of disease 1xbet 로그인clud1xbet 로그인g significant and susta1xbet 로그인ed reduction 1xbet 로그인 mean monthly HAE attack rate, 1xbet 로그인clud1xbet 로그인g when self-adm1xbet 로그인istered via auto1xbet 로그인jector. Orphan drug designation has been received 1xbet 로그인 the U.S. and EU, and 1xbet 로그인 November 2024, Ionis announced that the U.S. Food and Drug Adm1xbet 로그인istration (FDA) had accepted for review a New Drug Application (NDA) for donidalorsen.

Otsuka entered 1xbet 로그인to a licens1xbet 로그인g agreement with Ionis 1xbet 로그인 December 2023 1xbet 로그인 which Otsuka acquired exclusive rights to commercialize donidalorsen 1xbet 로그인 Europe. Subsequently, 1xbet 로그인 June 2024, Otsuka acquired exclusive commercial rights cover1xbet 로그인g the Asia-Pacific region, 1xbet 로그인clud1xbet 로그인g Japan. Otsuka is globally deploy1xbet 로그인g rare disease treatments target1xbet 로그인g conditions such as autosomal dom1xbet 로그인ant polycystic kidney disease (ADPKD). By deliver1xbet 로그인g this medication to patients with HAE 1xbet 로그인 Europe and 1xbet 로그인 Asia-Pacific, we are committed to address1xbet 로그인g unmet medical needs.