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\nJOAN TUR TORRES<\/p>\n
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\u4eca\u5e74\u306e\u521d\u3081\u306bClarivate Analytics\u304c\u767a\u8868\u3057\u305fDrugs to Watch 2019\u30ec\u30dd\u30fc\u30c8<\/a>\u306e\u4e2d\u3067\u30012019\u5e74\u306b\u4e0a\u5e02\u3055\u308c\u308b\u3068\u4e88\u6e2c\u3055\u308c\u305f7\u3064\u306e\u54c1\u76ee\u30922023\u5e74\u307e\u3067\u306e\u30d6\u30ed\u30c3\u30af\u30d0\u30b9\u30bf\u30fc\u5019\u88dc\u3068\u3057\u3066\u6ce8\u76ee\u3057\u307e\u3057\u305f\u3002<\/p>\n \u3053\u306e\u3046\u3061\u3001\u73fe\u5728\u306e\u5e02\u5834\u3067\u6700\u3082\u85ac\u4fa1\u304c\u9ad8\u3044\u533b\u85ac\u54c1\u306e\uff11\u3064\u3068\u306a\u3063\u305fZolgensma\u3092\u542b\u30803\u54c1\u76ee\u304c\u73fe\u6642\u70b9\u3067\u627f\u8a8d\u3055\u308c\u3066\u3044\u307e\u3059<\/a>\u304c\u3001\u3053\u308c\u3089\u30d6\u30ed\u30c3\u30af\u30d0\u30b9\u30bf\u30fc\u5019\u88dc\u306e\u73fe\u72b6\u306b\u3064\u3044\u3066\u307e\u3068\u3081\u307e\u3057\u305f\u3002 <\/p>\n Earlier this year, we released\u00a0the Cortellis Drugs to Watch 2019 report<\/a>, which highlighted seven drugs expected to launch in 2019 and become blockbusters in 2023. We have subsequently\u00a0reported on three of those drugs that have now gained approval<\/a>, including Zolgensma which entered the market as the most expensive drug ever launched.\u00a0Since that time, Rinvoq (upadacitinib) has been approved and launched in the U.S.; Ultomiris has been launched in the EU and Japan and received additional U.S. approval for a second indication; and Evrenzo (roxadustat) has been approved in Japan and its label expanded in China. Meanwhile, Palforzia (AR-101) has faced some delays and its regulatory filing is still under FDA evaluation.\u00a01-8<\/sup><\/p>\n <\/p>\n Rinvoq launches in the U.S. and gets positive CHMP opinion<\/strong><\/p>\n Rinvoq, AbbVie\u2019s oral JAK1-selective inhibitor, received U.S. approval in rheumatoid arthritis (RA) in August 2019, launching shortly after.1,2<\/sup>\u00a0Rinvoq has demonstrated remarkable efficacy in a wide range of RA settings, achieving all primary and ranked secondary endpoints in the phase III SELECT program. By leveraging these data, in particular,\u00a0 superior efficacy to best-in-class Humira, Rinvoq stands to gain a substantial share of the crowded RA market.1<\/sup><\/p>\n The product is also being reviewed for approval in Japan and the EU, with the EMA\u2019s Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion in October 2019.9<\/sup>\u00a0\u00a0The Cortellis Analytics \u2013 Drug Timeline & Success Rates tool<\/a>\u00a0forecasts EU approval in December 2019 and Japan approval in June 2020, with a likelihood of success of 95% for both regions.<\/p>\n <\/p>\n Ultomiris now available in multiple markets<\/strong><\/p>\n Alexion Pharmaceuticals received Japanese and EU approval for its complement inhibitor Ultomiris in June and July 2019, respectively, followed by launches in those regions.3, 4<\/sup>\u00a0Ultomiris is a next-generation follow-on to Alexion\u2019s market-leading Soliris for paroxysmal nocturnal hemoglobinuria, a rare and progressive blood disorder that is fatal in approximately 50% of cases. Ultomiris has the potential to become the new standard of care over Soliris by leveraging its non-inferiority and greatly improved dosing convenience (every eight weeks versus every two weeks).10<\/sup><\/p>\n Ultomiris also received additional U.S. approval in October 2019 for atypical hemolytic uremic syndrome (aHUS), an ultra-rare disease that causes progressive kidney failure and can lead to death. Ultomiris is also set to replace Soliris in this setting.5<\/sup>\u00a0Filings for aHUS in the EU and Japan are also being reviewed, with the\u00a0Cortellis Drug Timeline & Success Rates tool<\/a>\u00a0forecasting a 95% likelihood of approval in mid-2020 for both regions.<\/p>\n <\/p>\n Evrenzo gets approval in Japan for anemia with CKD and secures label expansion China<\/strong><\/p>\n AstraZeneca\/FibroGen\/Astellas\u2019 Evrenzo, a first-in-class oral HIF-PH inhibitor, received Japanese approval in September 2019 for anemia in chronic kidney disease (CKD) patients on dialysis.6<\/sup>\u00a0In Mainland China, a label expansion to include non-dialysis-dependent patients was approved in August 2019.7<\/sup><\/p>\n In the U.S. and EU, submissions for both dialysis-dependent and dialysis-independent patients are being prepared.11<\/sup>\u00a0Evrenzo showed no increased risk in major cardiovascular events compared with epoetin alfa in a pooled safety analysis required by the FDA and the EMA.12<\/sup>\u00a0The\u00a0Cortellis Drug Timeline & Success Rates tool<\/a>\u00a0forecasts a 90% chance of approval for both regions.<\/p>\n <\/p>\n Palforzia moves closer to approval despite delays<\/strong><\/p>\n Palforzia, Aimmune Therapeutics\u2019 oral desensitization immunotherapy for peanut allergy, is under review for U.S. approval. Two setbacks have delayed the drug\u2019s potential market entry: The U.S. government shutdown in December 2018\/January 2019 and the FDA decision to consider Palforzia an allergenic product candidate and therefore not eligible for expedited review associated with its Fast Track and Breakthrough Therapy designations.8<\/sup>\u00a0Despite discussions with the FDA, the filing was given a 12-month target period with an action date expected in late January 2020. However, Palforzia is now closer to becoming the first FDA-approved therapy for peanut allergy, following a positive recommendation from the Allergenic Products Advisory Committee (APAC) in September 2019.13<\/sup><\/p>\n In the EU, a filing was submitted in June 2019 and is currently under review.14<\/sup>\u00a0\u00a0The\u00a0Cortellis Drug Timeline & Success rates tool<\/a>\u00a0forecasts a 95% probability of approval, in October 2020.<\/p>\n <\/p>\n
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