Hyderabad: Laurus Labs launches innovative paediatric HIV Drug

Hyderabad : Hyderabad-based leading pharmaceutical and biotechnology firm Laurus Labs 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 children and infants.

As a component of antiretroviral (ARV) therapy for HIV/AIDS, Dolutegravir is presented as a second option for managing symptoms that align with the disease. Presently, the medication is obtainable in several dosages in the form of both pills and liquid suspension.

This innovative paediatric drug through ODF technology developed by Laurus Labs will simplify the drug administration in children and will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment. Laurus Labs was also the first generic approved company for a fixed dose combination of Abacavir/Dolutegravir/Lamivudine 600/50/300 mg, which is being used to treat HIV patients for second line of treatment.

Commenting on the US FDA approval, Dr Satyanarayana Chava, founder and CEO of Laurus Labs, said, “We are happy to receive the USFDA tentative approval for the World’s First Paediatric ARV drug Dolutegravir 5 mg and 10 mg, ODF. This option will help in strict compliance and adherence in the HIV treatment and benefit caretakers. Speaking to The Hans India, spokesperson, Laurus Labs, said, “ODF drugs are easy to administer to infants and children. As the medicine is in the form of film, it dissolves very easily once it is inserted on the tongue of the infant or child. This is a significant breakthrough in compliance in the paediatric HIV treatment.”

On a global scale, the prevalence of HIV among children is considerably higher than adults. As per the statistics released by the World Health Organization (WHO) in 2021, almost 1.7 million children below the age of 14 have been identified as HIV-infected. Moreover, the WHO’s estimation suggests that roughly 1,60,000 additional children contract the virus each year, and approximately 1,00,000 children perish as a result of it.

According to the India HIV Estimates 2021 report by the National AIDS Control Organisation (NACO), there were an estimated 69,808 children under the age of 15 who were afflicted with HIV in India. This particular demographic represents three percent of the overall HIV-infected population in the country.

At the national level, estimated adult HIV prevalence (15-49 years) has declined since the epidemic’s peak in 2000 where prevalence was estimated at 0.55 percent in 2000, through to 0.32 percent in 2010, and 0.21 percent in 2021. The northeast region States have the highest adult HIV prevalence (2.70 percent in Mizoram, 1.36 percent in Nagaland and 1.05 percent in Manipur), followed by southern States (0.67 percent in Andhra Pradesh, 0.47 percent in Telangana and 0.46 percent in Karnataka). The number of People Living with HIV (PLHIV) are estimated at around 24 lakhs.