{"id":35124,"date":"2018-10-19T11:32:36","date_gmt":"2018-10-19T11:32:36","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=35124"},"modified":"2018-10-19T13:44:00","modified_gmt":"2018-10-19T13:44:00","slug":"dolutegravirlamividune-fdc-submitted-to-ema-and-fda","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/35124","title":{"rendered":"Dolutegravir\/lamividune FDC submitted to EMA and FDA"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n

On 17 October 2018, ViiV healthcare announced that the dual-drug fixed dose combination FDC) of dolutegravir\/lamivudine had been submitted to the US FDA. [1]<\/span><\/b><\/p>\n

Submission is based on results from the phase 3 GEMINI studies in treatment naive participants that were presented at the AIDS 2018 conference in July. [2, 3]<\/span><\/p>\n

These results showed dolutegravir\/3TC to be non-inferior to triple therapy using dolutegravir plus tenofovir-DF\/emtricitabine.<\/span><\/p>\n

The FDA submission included a priority review voucher which shortens the decision timeline to six months. <\/span>These vouchers are bought and sold by companies and enable a faster review process.<\/p>\n

The dolutegravir\/lamivudine FDC was also submitted to the EMA on 14 September 2018. [4]<\/span><\/p>\n

Reference<\/span><\/p>\n

    \n
  1. ViiV press statement. ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV. (17 October 2018).
    \nhttps:\/\/www.viivhealthcare.com\/media<\/a><\/li>\n
  2. Cahn P et al. Non-inferior efficacy of dolutegravir (DTG) plus lamivudine (3TC) versus DTG plus tenofovir\/emtricitabine (TDF\/FTC) fixed-dose combination in antiretroviral treatment-na\u00efve adults with HIV-1 infection – 48-week results from the GEMINI studies. AIDS 2018, 23-27 July 2018, Amsterdam. Late breaker oral abstract TUAB0106LB.
    \n    http:\/\/programme.aids2018.org\/Abstract\/Abstract\/13210<\/a>\u00a0(abstract)
    \n    https:\/\/youtu.be\/pgmb1Fi63Fo?t=3642\u00a0<\/a>(webcast)<\/li>\n
  3. Collins S. DTG\/3TC dual therapy is non-inferior to triple-ART in GEMINI study
    \n    https:\/\/i-base.info\/htb\/34647<\/a><\/li>\n
  4. ViiV press statement. ViiV Healthcare submits regulatory application to European Medicines Agency for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV. (14 September 2018).
    \n<\/span>    https:\/\/www.viivhealthcare.com\/media<\/a><\/li>\n<\/ol>\n

    \u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 17 October 2018, ViiV healthcare announced that the dual-drug fixed dose combination FDC) of dolutegravir\/lamivudine had been submitted to the US FDA. [1] Submission is based on results from the phase 3 GEMINI studies in …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-35124","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/35124","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=35124"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/35124\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=35124"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=35124"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=35124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}