Aurobindo Pharma Ltd has announced the launch of its HIV triple combination product for children living with HIV in low- and middle-income countries.
Aurobindo has a paediatric dolutegravir voluntary licence with ViiV Healthcare. This enabled the company to develop and supply this product in 123 low and middle-income countries (LMIC), including India.
In a release shared by the company, the United States Food and Drug Administration (USFDA) has provided a tentative approval for the first generic dispersible tablet formulation of the fixed-dose combination Abacavir 60 mg + Lamivudine 30 mg + Dolutegravir 5 mg (pALD), for the treatment of children living with HIV.
This comes under the United States President's Emergency Plan For AIDS Relief (PEPFAR) programme.
The product will be available for treating children living with HIV weighing 6 kg to less than 25 kg and aged at least three months. It is for treating human immunodeficiency virus type 1 (HIV1).
The tablet would need to be administered by dissolving in water. It can be consumed once a day and comes in a strawberry flavour. The number of tablets would be based on the weight of the child and be determined by the prescribing physician. It will be available in pack size of 180 for multi-month dispensing.
Aurobindo's product has already been filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon.
The dispersible fixed-dose combination of abacavir, dolutegravir and lamivudine is identified by the World Health Organisation as a priority anti-retroviral therapy (ART) option for children living with HIV.
K Nithyananda Reddy, the vice chairman & managing director of Aurobindo said, "We are extremely glad that with this approval, more than a million children could benefit from this product thereby helping to increase the treatment coverage of children in 123 countries. It will be our endeavor to make this product accessible as soon as possible."
Helen McDowell, the head of government affairs & global public health at ViiV Healthcare, said, "Today's news is an important step forward in ensuring children living with HIV can access appropriate care and reinforces our commitment to leave no person living with HIV behind."