ViiV Healthcare statement on Mylan’s FDA tentative approval for a scored 10mg dolutegravir (DTG) dispersible tablet formulation

ViiV is delighted by the announcement of Mylan Laboratories Limited’s (now a subsidiary of Viatris) tentative approval under the US FDA President’s Emergency Plan for AIDS Relief (PEPFAR) scheme for a scored 10mg dolutegravir (DTG) dispersible tablet formulation for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in paediatric patients at least 4 weeks old and weighing at least 3 kg.

This milestone is the result of the public-private partnership between Unitaid, Clinton Health Access Initiative (CHAI), ViiV Healthcare and Mylan. Mylan Laboratories Limited was one of two generic manufacturers holding paediatric dolutegravir sub-licenses from the Medicines Patent Pool (MPP) that 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 living with HIV in resource-limited settings. The other generic manufacturer receiving such support is Macleods Pharmaceuticals Limited and its formulation of dispersible dolutegravir for children is currently under review under the US FDA President’s Emergency Plan for AIDS Relief (PEPFAR) scheme.