ViiV HEALTHCARE STATEMENT ON AUROBINDO AND MYLAN FDA TENTATIVE APPROVALS FOR A DISPERSIBLE TABLET FORMULATION OF THE FIXED DOSE COMBINATION OF ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE, FOR USE IN PAEDIATRIC PATIENTS AGED 3 MONTHS AND ABOVE AND WEIGHING 6KG TO <25KG
5th September 2023: ViiV Healthcare welcomes the news that both Aurobindo Pharma Limited and Mylan Laboratories Limited (a subsidiary of Viatris) have received tentative approval under the US FDA President’s Emergency Plan for AIDS Relief (PEPFAR) scheme for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine, for the treatment of HIV-1 infection in paediatric patients aged at least 3 months and weighing at least 6 kg to <25 kg.
This milestone is the result of public-private partnerships between Clinton Health Access Initiative (CHAI), Unitaid, ViiV Healthcare and each of the two generic manufacturers, both of whom hold paediatric dolutegravir voluntary licences either through the Medicines Patent Pool Foundation (MPP) or directly with ViiV. Over the last 3 years, Aurobindo and Mylan have both been provided with technical expertise by ViiV and regulatory support from CHAI (funded by Unitaid) to accelerate the development and registration of generic dispersible formulations of the fixed dose combination of abacavir, dolutegravir and lamivudine – the first dispersible single-tablet regimen containing dolutegravir – to enable broad and affordable supply for children living with HIV in resource-limited settings as quickly as possible.
An obvious barrier to treatment is that for young children, tablets can be hard to swallow or unpleasant in taste, presenting a real challenge to many caregivers’ ability to administer life-saving medicine. The availability of age-appropriate treatment is critical in ensuring the 1.5 million children and infants living with HIV1 can access optimal HIV care, and today’s news marks an important step forward in closing the gap between treatment options available for adults and children living with HIV in low- and middle-income countries.
The views expressed in this news update are entirely those of ViiV Healthcare and do not necessarily represent those of CHAI, its donors, Aurobindo Pharma Limited, Mylan Laboratories Limited or any other party.