Aurobindo Receives Tentative FDA Nod for Pediatric HIV Treatment

Highlights:

Aurobindo Pharma gets tentative FDA approval for a generic dispersible tablet for pediatric HIV treatment
The drug, recognized by WHO, will be introduced in 123 LMICs, backed by a voluntary license from ViiV Healthcare
Over a million children are poised to benefit, boosting treatment coverage across these nations

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

AIDS/HIV - Prevention And Transmission
Encyclopedia section of medindia explains in brief about the prevention for AIDS/HIV

‘Aurobindo Pharma has gained tentative FDA approval for a dispersible tablet designed for pediatric HIV treatment.’

Tweet it Now

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.

AIDS and Pregnancy
The Acquired immune deficiency syndrome is brought about by the deadly human immunodeficiency virus. In the USA alone an estimate of 120,000 - 160,000 women are HIV- infected.

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.

AIDS / HIV - Treatment
Encyclopedia section of medindia explains in brief about the treatment for AIDS/HIV

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.

Reference: