ViiV Health's compound new drug Juluca is approved by Japan's Ministry of Health, Labour and Welfare
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, ViiV Health(http:// announcedthat its two-in-onenewdrug(http://Juluca (dolutegravir/rilpivirine, dotiravir/ripivirin, 50mg/25mg tablets) has been approved by the Ministry of Health, Labour and Welfare (MHLW) as a-http:// drug to the http://ViiV submitted Juluca's application for a new drug in Japan on August 1 this year, and it took just over three months to approve itThis approval makes Juluca the first and only complete treatment for a single tablet 2 drug approved in the Japanese marketJulucaJuluca is a two-in-one compound disc, in which dolutegravir (dotiriver, DTG, developed by ViiV) is an HIV-integrated enzyme chain transfer inhibitor (INSTI), rilpivirine (lipivirin, RPV, developed by Johnson and Johnson) is a non-nucleoside reverse enzyme inhibitor (NNRTI)medication, the usual initial dose is one tablet, once daily, orally with the meal or immediately after the mealJuluca cannot be used with other drugs containing dotiravirWhen Juluca is used in combination with rifabutin, 25mg of lipilavirin should be taken once a day at the same timeWhen you stop lifo pudding combined, you should also stop taking lipilvirin aloneDo not take any drugs containing libiclean except when using lipila in conjunction with Liffordpudding in the United States and the European Union, Juluca was approved by the FDA (http:// and EMA in November 2017 and May 2018 as a long-term maintenance therapy for viral use in antiretroviral programs that have been accepted for at least 6 months of stability Inhibited (HIV-1 RNA 50 copy/ml) and has no history of virology failure, and HIV-1 adult infection without known or suspected drug-resistant mutations in any non-nucleoside retroviruse inhibitor (NNRTI) or integrated enzyme inhibitor (INSTI) related studies Juluca's approval is based on data from Phase III clinical program SWORD The project enrolled more than 1,000 previously accepted 3 or 4 drugs (based on integrated enzyme inhibitors, non-nucleoside retrovirus inhibitors, or protease inhibitors) to achieve virological inhibition of HIV-1 infections, and assessed the efficacy, safety and tolerance of patients moving from 3 or 4 drug to 2 drug regimens the program includes two Phase III clinical studies (SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797), both 148-week, randomized, open label, non-disadvantage-effect studies of these two studies, dolutegravir and rilpivirine were taken in separate tablets, taken daily, and 48 weeks of research data were published at the Congress (http:// of the November 2017 and Opportunity for New Infections (CROI) and published in The Lancet in March 2018
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