Indian pharma firm’s first-of-its-kind AIDS drug for children gets FDA approval
Hyderabad-based pharmaceutical firm Laurus Labs has received in-principle approval from the United States Food and Drugs Administrator (FDA) to launch the world’s first Oral Dispersible Film (ODF) drug, Dolutegravir, for treating HIV/AIDS in kids and infants.
Dolutegravir, as part of antiretroviral (ARV) treatment for HIV/AIDS, is offered as a second line of treatment for conditions consistent with the disease. Currently, different dose strengths of the drug are available in the form of pills and liquid suspension.
The innovative paediatric drug will simplify administration among children, said the company, adding that its ODF administration technology will also help in ensuring improved compliance of ARV medication among children afflicted with HIV.
Laurus Labs was also the first company in the world to receive an approval from the FDA for its generic drug — a fixed dose combination of Abacavir/Dolutegravir/Lamivudine 600/50/300 mg — which is being used in the second-line treatment of adult HIV patients.
Commenting on the US FDA approval, Satyanarayana Chava, founder and CEO of Laurus Labs, said that this drug will not only improve compliance among children afflicted with HIV, but also benefit caregivers.
It is estimated that worldwide, HIV is a much more common problem among children compared to adults. In 2021, nearly 1.7 million children under the age of 14 years had been diagnosed with HIV infection, according to figures released by the World Health Organisation (WHO). The WHO also estimates that around 1,60,000 more children are infected with HIV and about 1,00,000 children succumb to it every year.
In India, the National Aids Control Organisation (NACO) had in its India HIV Estimates 2021 report estimated that there were 69,808 children below the age of 15 living with HIV in the country. These children accounted for three per cent of the total number of Indians living with the infection in India.