Aurobindo Pharma gets tentative FDA approval for generic HIV treatment for children

Aurobindo Pharma Limited has achieved a significant milestone by securing the US Food and Drug Administration (FDA)’s tentative nod under the PEPFAR program for its generic dispersible tablet, a fixed-dose combination of Abacavir 60mg, Lamivudine 30 mg, and Dolutegravir 5 mg (pALD). This formulation is pivotal for treating children afflicted with HIV, particularly those weighing between 6 kg and <25 kg and aged a minimum of 3 months. The pace of this generic combination’s approval is remarkable, closely following ViiV’s original FDA sanctioning in March 2022.

Aurobindo Pharma’s initiative has been strengthened by its paediatric dolutegravir voluntary license pact with ViiV Healthcare, which facilitates the product’s supply in 123 Low and Middle-Income Countries (LMICs), encompassing India. The product is already under review with the Drugs Controller General of India (DCGI) and anticipates the green light shortly.

This generic dispersible fixed dose has been spotlighted by the WHO as a crucial ART option for HIV-affected children. Given its generic nature, its accessibility will vastly expand in the LMIC region, making treatment affordable. Aurobindo’s infrastructure, backed by their FDA-approved facility, is primed to cater to the anticipated market demand, with commercial manufacturing projected for Q3 FY24.

Reflecting on this achievement, K. Nithyananda Reddy, the Vice Chairman & Managing Director of Aurobindo Pharma, remarked, “This landmark approval paves the way for over a million children across 123 nations to access and benefit from this vital treatment. Our commitment is to enhance its accessibility swiftly. This success is a testament to the collaborative synergy between ViiV Healthcare, CHAI, Unitaid, and Aurobindo.”

Echoing this sentiment, Helen McDowell, Head of Government Affairs & Global Public Health at ViiV Healthcare, emphasized, “Our collaboration with CHAI, Unitaid, and Aurobindo over the past three years has been instrumental in fast-tracking the creation and distribution of age-suitable HIV treatments in resource-limited areas. This development is a significant leap towards ensuring affected children can avail proper care, underscoring our pledge to support every individual grappling with HIV.”