USFDA tentative nod to Aurobindo Pharma's generic FDC drug to treat HIV in children

Hyderabad: Aurobindo Pharma Limited has announced USFDA tentative approval under the PEPFAR program for the first generic dispersible tablet formulation of the fixed dose combination Abacavir 60mg + Lamivudine 30 mg + Dolutegravir 5 mg (pALD), for the treatment of children living with HIV weighing 6 kg to <25 kg and aged at least 3 months.

Aurobindo has a paediatric dolutegravir voluntary licence with ViiV Healthcare, enabling the development and supply of this product in 123 Low and Middle-Income Countries (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 USFDA approval in March 2022. Aurobindo’s product is already filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon. The dispersible fixed dose combination of abacavir, dolutegravir and lamivudine is identified by the WHO as a priority ART option for children living with HIV, and this generic approval will help to enable broad and affordable supply in low- and middle-income countries.

Aurobindo has capacities in their FDA approved plant to meet the market demand for this product and commercial production will commence in Q3 FY24.

K. Nithyananda Reddy, Vice Chairman & Managing Director, Aurobindo said, “We are extremely glad that with this approval, 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 endeavor 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.”

Helen McDowell, Head of Government Affairs & Global Public Health, ViiV Healthcare, said, “ViiV is proud to have partnered with CHAI, Unitaid and Aurobindo over the last three years to accelerate the development and availability of generic age-appropriate HIV treatment in resource-limited settings. This news is an important step forward in ensuring children living with HIV can access appropriate care and reinforces our commitment to leave no person living with HIV behind.”

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