Aurobindo Pharma Ltd on Wednesday announced the launch of its HIV triple combination product for children living with HIV in low- and middle-income countries. Following this, the shares of Aurobindo Pharma opened flat and were trading at Rs 872.65 around 9.31 am on August 17 after the drug maker said it will launch a tablet to treat HIV in low-to-middle income countries.
According to media reports, 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.
According to a press statement on Wednesday, 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.
Reportedly, 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,” as the company’s press statement.
Meanwhile, the product has already been filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon.
The World Health Organization (WHO), the dispersible fixed-dose combination of abacavir, dolutegravir and lamivudine has been identified as a priority anti-retroviral therapy (ART) option for children living with HIV.
“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,” K Nithyananda Reddy, the vice chairman & managing director of Aurobindo said in a statement.
Headquartered in Hyderabad, Aurobindo Pharma manufactures a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries.
