01/13/2021 | Press release | Distributed by Public on 01/13/2021 03:02
London, 13 January 2021 - ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc ('GSK'), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Commission has granted Marketing Authorisation for Tivicay (dolutegravir) 5mg dispersible tablets, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg. This authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children 6 years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.
Deborah Waterhouse, CEO of ViiV Healthcare, said: 'Today's authorisation is a really important milestone towards enabling children to have access to age-appropriate formulations of HIV medicine. Globally there are approximately 1.7 million children living with HIV and around 100,000 children dying each year from AIDS which is why we won't stop doing all that we can to ensure that no child living with HIV is left behind.'
The EU Marketing Authorisation follows the US Food and Drug Administration (FDA) approval of Tivicay PD in 2020[i], providing an age-appropriate formulation of dolutegravir for a younger population to help to close the gap between HIV treatment options available for adults and children.
Amanda Ely, CEO of CHIVA (Children's HIV Association) said: 'As an organisation, we continue our efforts to help support young people and families living with HIV manage the challenges of lifelong treatment and today's authorisation helps to do this. Today's news is a positive step forward in helping the many children and infants who may struggle to take their medicines in tablet form.'
The Marketing Authorisation is based on data from the ongoing P1093[ii]and ODYSSEY[iii](PENTA20) studies, which are being conducted in collaboration with international paediatric research networks, IMPAACT and PENTA-ID.
Notes to editors:
About P10935 and ODYSSEY6
About voluntary licensing of paediatric dolutegravir
Currently 15 generic manufacturers hold voluntary licences for paediatric formulations of DTG: one direct license and 14 through the Medicines Patent Pool (MPP). Two generic manufacturers who hold paediatric dolutegravir sub-licences from the MPP- Mylan Laboratories Limited (Mylan) and Macleods Pharmaceuticals Limited (Macleods) - have been provided with the technical expertise of ViiV Healthcare and a financial incentive from Unitaid via CHAI, to accelerate the development, registration, manufacture and supply of generic dispersible formulations of dolutegravir for children in all low-income, all least developed, all lower-middle income, all Sub-Saharan African (SSA) and some upper middle-income countries as defined by World Bank Classifications at the date of signature of the licence agreement. Mylan and Macleods have both submitted a new drug application for a scored dolutegravir 10mg dispersible tablet with Mylan receiving tentative approval under the FDA President's Emergency Plan for AIDS Relief (PEPFAR) scheme at the end of 2020.
Tivicay contains dolutegravir, an integrase strand transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
Important Safety Information (ISI) for TIVICAY (dolutegravir) tablets, for oral use and TIVICAY (dolutegravir) dispersible tablet
The following ISI is based on the highlights section of the Prescribing Information for Tivicay. These highlights do not include all the information needed to use TIVICAY safely and effectively. See full prescribing information for TIVICAY.
Indications and Usage
TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least 4 weeks and weighing at least 3 kg.
TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.
Warnings and Precautions
Use in Specific Populations
Please see full prescribing information available at: https://www.medicines.org.uk/emc/product/5248/smpc#gref
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 are 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.
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 'Risk Factors' in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's 'Principle risks and uncertainties' section of the Q3 Results and any impacts of the COVID-19 pandemic.
[i]Tivicay (dolutegravir) US Prescribing Information. July 2020.
[ii]Clinicaltrials.gov. (2019). PH3b, DTG Study in HIV-1 Subjects Completing IMPAACT Study P1093. Available at: https://clinicaltrials.gov/ct2/show/NCT03016533 Last accessed: October 2020.
[iii]Clinicaltrials.gov. (2019). A Randomised Trial of Dolutegravir (DTG)-Based Antiretroviral Therapy vs. Standard of Care (SOC) in Children With HIV Infection Starting First-line or Switching to Second-line. Available at: https://clinicaltrials.gov/ct2/show/NCT02259127?term=PENTA20&draw=2&rank=1 Last accessed: October 2020.