Subj:【Janssen Pharmaceutical Co., Ltd.】 About manufacturing and marketing approval application for anti-HIV drug "darunavir ethanol adduct / cobiscistat / emtricitabine…
【Janssen Pharmaceutical Co., Ltd.】 About manufacturing and marketing approval application for anti-HIV drug “darunavir ethanol adduct / cobiscistat / emtricitabine / tenofovir araphenamid fumarate combination table”
Janssen Pharmaceutical Co., Ltd. Regarding application for manufacturing and marketing approval for anti-HIV drug “darunavir ethanol adduct / cobiscistat / emtricitabine / tenofovir araphenamid fumarate combination tablets” ………………………………………………………………………………… Janssen Pharma Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo, President and Chief Executive Officer: Chris Houligan, hereinafter referred to as Janssen) today announced that “Dalnavir ethanol adduct / cobiscistat / emtricitabine / tenofovir araphenamide fumarate combination tablet We have applied for marketing approval in Japan for adults and children (ages 12 and over and weighing 40 kg or more) for the purpose of scheduling “HIV-1 infection” for this product. This drug is a film-coated tablet containing a fixed dose of four components, 800 mg for darunavir (DRV), 150 mg for cobiscistat (COBI), 200 mg for emtricitabine (FTC) and 10 mg for tenofovir arafenamide (TAF). This is the first formulation of the key drug inhibitor protease in Japan for the first time in fixed dose combination tablets which can take internal tablets of the active ingredient of the regimen recommended by Japanese anti-HIV therapy guidelines 1 with 1 tablet once a day. Treatment of HIV infection is a long-term treatment, so it is important that patients actively participate in decision of therapeutic policy to receive treatment and improve medication adherence. Guidelines 1 for anti-HIV therapy in Japan “As prescribing once-a-day dosing is advantageous in order to maintain compliance rate, we should positively choose cases to start new treatment in the future” I will. In addition, in the meta-analysis of anti-HIV therapy, it is shown that the smaller the number of tablets daily taken, the higher the medication adherence and the virological inhibition rate 2. It contains active ingredients that have already been approved ※ This product designed to be orally administered with 1 tablet once a day is expected to improve patient’s adherence by reducing burden at the time of medication . COBI, FTC and TAF were developed by Gilead Sciences. Based on the license agreement with the company, Janssen has the right to develop and commercialize this drug in Japan. Janssen will continue to respond to medical needs that are not yet satisfied by providing new treatment options in the field of HIV and will work hard to improve the quality of life for HIV-infected patients. * 1 DRV is a protease inhibitor, COBI is a pharmacokinetic enhancing factor (booster), fixed dose combination tablets containing DRV 800 mg and COBI 150 mg are sold as “Plejicobicx compound tablets” in Japan, It is used in combination with other anti-HIV drugs as a treatment for HIV infection. Both FTC and TAF are nucleic acid reverse transcriptase inhibitors (NRTI), and the two-component fixed dose combination tablets are sold as “Desicobi Combination Tablets LT” and “Dishi Kobi Combination Tablets HT” in Japan, and in other classes It is used as a treatment for HIV-1 infection by combining with anti-HIV therapeutic drug. About HIV (Human Immunodeficiency Virus) Infection HIV infection is a life-threatening serious disease that is extremely important for public health, and it is reported that about 36.9 million people are affected worldwide in 2017 3. Meanwhile, in Japan, about 1,400 people have been annually reported as new HIV infection and acquired immunodeficiency syndrome (AIDS) patients annually, and the cumulative number of patients in 2017 has been reported to be about 20,750 people 4. Standard treatment of HIV infection Standard treatment for HIV infection is antiretroviral therapy aimed at inhibiting viral replication, increasing the number of CD4 positive lymphocytes and suppressing disease progression, using multiple anti-HIV therapeutic agents in combination. In Japanese anti-HIV therapy guidelines 1, the recommended regimen or alternative regimen for patients who are not experienced with anti-HIV therapy is in addition to the two NRTIs, which are backbone (a drug that complements key drag and has a role of enhancing virus suppression effect) , One drug key drug (a drug with more potent HIV suppression effect) is selected from three drug classes (integrase inhibitor, non-nucleic acid reverse transcriptase inhibitor or protease inhibitor) It is said to be viral therapy. With the advent of new drugs and their combination treatment, virus replication can be suppressed, and the life prognosis of HIV-infected patients has been remarkably improved. However, even now, drug treatment alone can not completely eliminate viruses from HIV-infected patients and it is necessary to continue lifelong treatment. References 1 Heisei 29 Health Labor Administration Promotion Survey Project Grant Subsidy HIV / AIDS Policy Research Project Research group to overcome the problems of HIV infection and its complications Guidelines for anti-HIV treatment March 2018. 2 Nachega JB, Parienti JJ, Uthman OA, et al. Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials. Clin Infect Dis. 2014 May; 58 (9): 1297- 307. 3 UNAIDS [homepage on the Internet]. Geneva: Joint United Nations Program on HIV / AIDS (UNAIDS). AIDS DATA. Available from: www.unaids.org/en/resources/aids_data 4 AIDS Prevention Information Network [homepage on the Internet]. Tokyo: AIDS prevention foundation public foundation foundation. AIDS trend committee report 2018. Available from: api-net.jfap.or.jp/status/2018/1803/20180316_HYO-02.pdf About Jansen Janssen, the pharmaceutical division of the Johnson & End Johnson Group, makes every effort to realize a disease free world. It is our hope to prevent, eradicate, treat and cure diseases better than ever and to contribute to people’s lives. And I always think about my patient and pursue the most promising science. We, Janssen, collaborate all over the world to connect people’s hopes and lives to tomorrow. For more information, please visit www.janssen.com.
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