Drugmaker Aurobindo Pharma has received the U.S. Food and Drug Administration’s tentative approval, under the U.S. President’s emergency plan for AIDS relief (PEPFAR) programme, for generic dispersible tablet formulation of the fixed dose combination Abacavir 60mg/Lamivudine 30 mg/Dolutegravir 5 mg. The drug is for the treatment of children living with HIV weighing 6-25 kg and aged at least three months.
The dispersible FDC has been identified by the World Health Organisation as a priority antiretroviral therapy (ART) option for children living with HIV, and this generic approval would help to enable broad and affordable supply in low- and middle-income countries LMIC. Aurobindo, which will be launching the product under voluntary licence from ViiV Healthcare, has capacities in its FDA-approved plant to meet the market demand for this product. The commercial production will commence in the third quarter of FY24, the company said on Wednesday.
Aurobindo has a paediatric dolutegravir voluntary licence with ViiV Healthcare, enabling development and supply of this product in 123 LMIC, including India. This is one of the fastest approvals for a generic combination product following approval of the innovator formulation, with ViiV having secured U.S. FDA approval in March 2022. The product has already been filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon, Aurobindo said.
“More than a million children could benefit from this product thereby helping to increase the treatment coverage of children in 123 countries. It will be our endeavour to make this product accessible as soon as possible. This has become a reality today by the excellent collaborative partnership between ViiV Healthcare, CHAI, Unitaid and Aurobindo,” vice chairman and MD K.Nithyananda Reddy said in a release.
