Aurobindo Pharma launches HIV triple combination product for children
The generic drug has received tentative approval from the USFDA under the US Presidents Emergency Plan for AIDS Relief (PEPFAR) Programme. The drug will be used in the treatment of children aged three months or older between 6-25 kg in weight in the low and middle income countries, including India.
Aurobindo Pharma has launched a triple HIV combination drug for treatment of children in low and middle-income countries. The drug will be produced under a voluntary license from ViiV Healthcare. The drug is the first generic alternative to receive a tentative approval from the United States Food and Drug Administration (USFDA) for the fixed-dose combination of Abacavir 60mg, Lamivudine 30 mg and Dolutegravir 5 mg (pALD).
The generic drug received tentative approval from the USFDA under the US President's Emergency Plan for AIDS Relief (PEPFAR) Programme. The drug will be used in the treatment of children aged three months or older between 6-25 kg in weight. The drug works as an anti-retroviral therapy (ART), identified as a priority treatment for children by the World Health Organization (WHO).
Aurobindo Pharma waits for DCGI approval for the product
Under the voluntary license with ViiV Healthcare, Aurobindo Pharma can produce and supply the drug in 123 low and middle-income countries, including India. The drug offering has already been sent for approval from the Drugs Controller General of India (DCGI), with the company hoping to start commercial production from its FDA-approved facility in Q3FY24.
ViiV Healthcare was created by Pfizer and GSK as a specialised HIV pharma company in 2009. Its pALD drug was submitted to USFDA for approval in 2022.
Aurobindo Pharma subsidiary receives USFDA approval
The Hyderabad-based pharma major also recently announced that its wholly-owned subsidiary company Eugia Pharma received the final approval from the FDA for its Icatibant Injection, which is the therapeutic equivalent to Firazyr, which is produced by Takeda Pharmaceuticals USA and has a market size of around $137 million.
Shares of Aurobindo Pharma were trading at Rs 871.50 apiece, down 0.22 percent, BSE at 12:31 PM.
The company’s stock has gained over 17 per cent in the past one-month period. Aurobindo Pharma’s stock price has increased more than 48 per cent in the last one year.
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