Aurobindo Receives Tentative FDA Nod for Pediatric HIV Treatment

Aurobindo Pharma has got tentative approval from the US Food and Drug Administration under the President’s Emergency Plan for AIDS Relief (PEPFAR) program for a generic dispersible tablet formulation of the fixed dosage combination Abacavir 60mg/Lamivudine 30 mg/Dolutegravir 5 mg (1^✔ ✔Trusted Source
Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)

). The medication is intended for the treatment of HIV-positive children aged three months and up who weigh 6-25 kg.

Dispersible FDC: Pivotal for Pediatric HIV Treatment

The World Health Organization has recognized dispersible FDC as a priority antiretroviral therapy (ART) option for children living with HIV, and its generic approval would help to enable widespread and inexpensive supplies in low- and middle-income countries LMIC. Aurobindo, which will introduce the medication under a voluntary license from ViiV Healthcare, has sufficient capacity in its FDA-approved facilities to meet market demand. The business said that commercial production will begin in the third quarter of FY24.

Pediatric Dolutegravir: ViiV License to DCGI Filing

Aurobindo has a voluntary paediatric dolutegravir license with ViiV Healthcare, which allows for the development and supply of this pharmaceutical in 123 LMICs, including India. It is one of the quickest approvals for a generic combination medication following innovator formulation clearance, with ViiV receiving U.S. FDA approval in March 2022. According to Aurobindo, the product has already been filed with the Drugs Controller General of India (DCGI) and is likely to be approved soon.

Expanding Pediatric HIV Treatment with Aurobindo, ViiV Healthcare

“More than a million children could benefit from this product thereby helping to increase the treatment coverage of children in 123 countries. We will 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.