Lupin's Generic HIV Treatment for Children Receives Tentative FDA Approval

The U.S. FDA has granted tentative approval to global pharmaceutical company Lupin Limited for its generic version of Triumeq PD tablets for oral suspension, a treatment for pediatric HIV.

This approval brings the medication one step closer to making HIV treatment more affordable and accessible for children in low- and middle-income countries, according to a news release by Lupin.

The medication, which combines Abacavir, Dolutegravir and Lamivudine, will be produced at Lupin’s Nagpur facility in India.

This new generic medicine is designed to be a simple, once-daily treatment for children as young as three months old who weigh at least 13 pounds.

According to the CDC, 1.37 million children are living with HIV, globally.

In 2023, the CDC tested over 3.5 million children and supported treatment for more than 300,000 children under 15 years old living with HIV.

Clinical trials have shown that the combination of Dolutegravir, Abacavir, and Lamivudine is effective in treating HIV.

In one study with 833 participants who had not received prior treatment, 88% of patients taking the higher dosage version of the Triumeq combination had undetectable levels of HIV after 48 weeks, compared to 81% in another treatment group.

The National Institutes of Health explained that HIV can pass from a birthing parent with HIV to their child during pregnancy, childbirth or breastfeeding. This process, called perinatal transmission of HIV, is the most common way children under 13 years old in the U.S. acquire HIV.

Additionally, HIV treatment in children is influenced by factors like growth and development. Since children grow at different rates, the dosage of HIV medicine often depends on a child’s weight rather than their age.

Medications such as Triumeq PD are designed to meet these specific needs, helping manage HIV in children and reduce the risk of the virus being passed from mothers to babies during pregnancy or breastfeeding.

These efforts relate to those of PEPFAR, the U.S. President’s Emergency Plan for AIDS Relief.

Since its launch in 2003, PEPFAR has invested over $100 billion in fighting HIV/AIDS globally. It has saved millions of lives and strengthened healthcare systems, particularly in low-income areas.

As PEPFAR keeps making a difference, the new generic version from Lupin is expected to lower the cost of HIV treatment, the release said.

Currently, Triumeq PD costs about $1,230 for a 90-tablet supply.

By offering a lower-cost alternative, Lupin’s medicine could help many more children access the treatment they need.

While Lupin awaits full FDA approval, the potential impact of its generic Triumeq PD is clear and could change the lives of children with HIV and their families.