DovatoTreatment for HIV Infection
Update: Dovato (dolutegravir and lamivudine) Now FDA Approved - April 8, 2019
ViiV Healthcare Submits New Drug Application to FDA for Single-Tablet, Two-Drug Regimen of Dolutegravir and Lamivudine for Treatment of HIV
London - 18 October 2018 ViiV Healthcare today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection.
The submission is based on the global GEMINI 1 & 2 studies that included more than 1400 HIV-1 infected adults with baseline viral loads up to 500,000 c/mL. The results of these studies were presented at the 2018 International AIDS Society meeting in July.
Deborah Waterhouse, CEO, ViiV Healthcare, said, “We have now entered an exciting new era of treatments for people living with HIV. ViiV Healthcare believes that a two-drug regimen has the potential to be an important option for many who may spend their lifetime taking drugs to control their virus. This regulatory submission is the next step in the two-drug regimen journey and reinforces our belief that many patients can control their disease with two drugs instead of three or more.”
John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV Healthcare, said: “This NDA, if approved, will provide a single-tablet, two-drug regimen option with DTG and 3TC that we believe could have an impact on the existing HIV treatment strategy and serve as a valuable option for people living with HIV. ViiV Healthcare is committed to challenging the status quo with innovations that are based on our belief that no one should take more medicines than they need.”
A priority review voucher was submitted to the FDA along with the NDA. Under the Prescription Drug User Fee Act, the anticipated target action date for this NDA with a priority review voucher is six months after receipt of the application by the FDA. A marketing authorisation application (MAA) to the European Medicines Agency (EMA) was submitted in September and other global regulatory submissions for DTG and 3TC as a single-tablet, two-drug regimen for HIV-1 therapy are anticipated in the coming months.
GEMINI 1 & 2 Study Design
GEMINI 1 (204861) and GEMINI 2 (205543) are duplicate, phase III, randomised, double-blind, multicentre, parallel group, non-inferiority studies. These studies evaluate a two-drug regimen of dolutegravir and lamivudine compared with a three-drug, first-line regimen of DTG + TDF/FTC in HIV-1 infected, antiretroviral therapy (ART)-naïve adult participants with baseline HIV-1 viral loads up to 500,000 copies per mL. The trials are designed to study the efficacy, safety, and tolerability of once-daily dolutegravir and lamivudine compared to once-daily dolutegravir and the fixed-dose combination of TDF/FDC at 48 weeks in HIV-1-infected, ART-naïve participants. The GEMINI studies are ongoing for 148 weeks. For more information please search for NCT02831673 (GEMINI 1) or NCT02831764 (GEMINI 2) on www.clinicaltrials.gov.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
Cautionary statement regarding forward-looking statements
ViiV Healthcare Limited, the global specialist HIV company, is majority owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi Limited. GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2017.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Posted: October 2018
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