Recommendation based on landmark GEMINI 1 & 2 studies which demonstrated non-inferior efficacy of dolutegravir + lamivudine compared to a traditional dolutegravir-based, three-drug regimen, in HIV-1 infected, treatment-naïve adults
LONDON, UK I April 26, 2019 I ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for Dovato, for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine[1].
John C. Pottage, Jr, M.D. Chief Scientific Medical Officer, ViiV Healthcare, said: “Advances in HIV treatment mean that people living with HIV are living longer, and are taking daily medication over a longer period of time. With our portfolio of two-drug regimens, with dolutegravir at the core, we are establishing a new way of treating HIV which challenges the three-drug regimen standard of care. This means that people living with HIV may take fewer drugs while having the same efficacy outcomes. Today’s CHMP Positive Opinion for Dovato is an important step towards providing treatment-naïve people living with HIV in Europe the first once-daily, single-pill, complete 2-drug regimen for the treatment of HIV.”
The Marketing Authorisation Application for the once-daily, single-pill, 2-drug regimen of Dovato is supported by data from the landmark global GEMINI 1 & 2 studies that included more than 1,400 HIV-1 infected adults. In these studies, dolutegravir + lamivudine demonstrated non-inferior efficacy based on plasma HIV-1 RNA <50 copies per millilitre (c/mL), a standard measure of HIV control, at Week 48 when compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected adults. The safety results for dolutegravir + lamivudine seen in GEMINI 1 & 2 were consistent with the product labelling for dolutegravir and lamivudine. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance[2].
A CHMP Opinion is one of the final steps before a marketing authorisation decision is made by the European Commission (EC). A final EC decision is anticipated within the coming months. Dovato has been approved by the US Food and Drug Administration[3] and further regulatory applications have been submitted worldwide.
Notes to editors
About dolutegravir and lamivudine
Dolutegravir is an integrase inhibitor (INI) for use in combination with other antiretroviral agents for the treatment of HIV[4]. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Dolutegravir is approved in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.
Lamivudine, commonly known as 3TC, is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection. Lamivudine is available in branded (Epivir®) and generic forms[5].
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
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 in October 2012. The company’s aims 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.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us/.
Cautionary statement regarding forward-looking statements
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 2018.
References
[1] European Medicines Agency. Press releases. Available at https://www.ema.europa.eu/en/search/search/ema_editorial_content/ema_news?sort=field_ema_public_date&order=desc. Last accessed April 2019
[2] Cahn J, Sierra Madero J, Arribas J, et al. Non-inferior efficacy of dolutegravir (DTG) plus lamivudine (3TC) versus DTG plus tenofovir/emtricitabine (TDF/FTC) fixed-dose combination in antiretroviral treatment-naïve adults with HIV-1 infection – 48-week results from the GEMINI studies. AIDS 2018.
[3] Dovato (dolutegravir/lamivudine) Prescribing Information. U.S. Approval 8 April 2019.
[4] Tivicay (dolutegravir) European Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/tivicay- epar -product-information_en.pdf. Last accessed February 2019.
[5] European Medicines Agency. Epivir (lamivudine) European Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/epivir- epar -product-information_en.pdf. Last accessed February 2019.
SOURCE: GlaxoSmithKline
Post Views: 54
Recommendation based on landmark GEMINI 1 & 2 studies which demonstrated non-inferior efficacy of dolutegravir + lamivudine compared to a traditional dolutegravir-based, three-drug regimen, in HIV-1 infected, treatment-naïve adults
LONDON, UK I April 26, 2019 I ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for Dovato, for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine[1].
John C. Pottage, Jr, M.D. Chief Scientific Medical Officer, ViiV Healthcare, said: “Advances in HIV treatment mean that people living with HIV are living longer, and are taking daily medication over a longer period of time. With our portfolio of two-drug regimens, with dolutegravir at the core, we are establishing a new way of treating HIV which challenges the three-drug regimen standard of care. This means that people living with HIV may take fewer drugs while having the same efficacy outcomes. Today’s CHMP Positive Opinion for Dovato is an important step towards providing treatment-naïve people living with HIV in Europe the first once-daily, single-pill, complete 2-drug regimen for the treatment of HIV.”
The Marketing Authorisation Application for the once-daily, single-pill, 2-drug regimen of Dovato is supported by data from the landmark global GEMINI 1 & 2 studies that included more than 1,400 HIV-1 infected adults. In these studies, dolutegravir + lamivudine demonstrated non-inferior efficacy based on plasma HIV-1 RNA <50 copies per millilitre (c/mL), a standard measure of HIV control, at Week 48 when compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected adults. The safety results for dolutegravir + lamivudine seen in GEMINI 1 & 2 were consistent with the product labelling for dolutegravir and lamivudine. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance[2].
A CHMP Opinion is one of the final steps before a marketing authorisation decision is made by the European Commission (EC). A final EC decision is anticipated within the coming months. Dovato has been approved by the US Food and Drug Administration[3] and further regulatory applications have been submitted worldwide.
Notes to editors
About dolutegravir and lamivudine
Dolutegravir is an integrase inhibitor (INI) for use in combination with other antiretroviral agents for the treatment of HIV[4]. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Dolutegravir is approved in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.
Lamivudine, commonly known as 3TC, is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection. Lamivudine is available in branded (Epivir®) and generic forms[5].
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
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 in October 2012. The company’s aims 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.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us/.
Cautionary statement regarding forward-looking statements
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 2018.
References
[1] European Medicines Agency. Press releases. Available at https://www.ema.europa.eu/en/search/search/ema_editorial_content/ema_news?sort=field_ema_public_date&order=desc. Last accessed April 2019
[2] Cahn J, Sierra Madero J, Arribas J, et al. Non-inferior efficacy of dolutegravir (DTG) plus lamivudine (3TC) versus DTG plus tenofovir/emtricitabine (TDF/FTC) fixed-dose combination in antiretroviral treatment-naïve adults with HIV-1 infection – 48-week results from the GEMINI studies. AIDS 2018.
[3] Dovato (dolutegravir/lamivudine) Prescribing Information. U.S. Approval 8 April 2019.
[4] Tivicay (dolutegravir) European Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/tivicay- epar -product-information_en.pdf. Last accessed February 2019.
[5] European Medicines Agency. Epivir (lamivudine) European Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/epivir- epar -product-information_en.pdf. Last accessed February 2019.
SOURCE: GlaxoSmithKline
Post Views: 54
