HQ Team
March 30, 2023: Aurobindo Pharma, an Indian maker of generic pharmaceuticals and active pharmaceutical ingredients, announced it signed a voluntary sub-licensing with a UN body for developing and marketing a drug to prevent HIV.
The pact was signed with Medicines Patent Pool, a UN organisation, for Cabotegravir tablets & long-acting injectables, originally developed by ViiV Healthcare.
It will be selling medicines in 90 low and middle-income countries, including India, according to a BSE filing.
The Hyderabad, India-based company —for the generic version of Cabotegravir —will utilise their vertically-integrated capabilities to develop in-house API manufacturing, which will enable stronger control of the supply chain and cost efficiencies.
The tablet and injectable dosage forms of the product will be produced at the APL Healthcare Unit IV, Naidupet, India, and at the new Eugia Sterile facility, Vizag, India.
Adequate capacity
The company has adequate capacities of world-class standards to meet the global demand for the product across the licensed territory, said K. Nithyananda Reddy, Vice-Chairman & Managing Director of Aurobindo.
“This is the first time a longer-acting injectable product for the prevention of human immunodeficiency virus (HIV) infection will be made available in low and middle-income nations.
“This product will be a good addition to Aurobindo’s antiretrovirals (ARV) portfolio and will further strengthen our leadership in the generic HIV medicine space,” he said.
The company aims to help reduce the risk of HIV type 1 (HIV-1) infection in certain adults and adolescents weighing at least 35 kilograms.
Charles Gore, Executive Director of the Medicines Patent Pool, said: “Broadening access to this innovative long-acting HIV prevention medicine could significantly contribute to ending HIV transmission by providing people with a choice in their HIV prevention options.”
Longer-acting injectable
Cabotegravir long-acting (LA) injectable suspension for HIV prevention is the first and only longer-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV spread, according to the filing.
Pre-exposure prophylaxis (PrEP) is the process of taking a prescription drug as a means of preventing HIV infection in an HIV-negative person.
Cabotegravir LA for PrEP is provided as an injection administered six times per year and is initiated with a single 600 mg (3 ml) injection given one month apart for two consecutive months.
After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3 ml) injection given every two months.
Cabotegravir oral tablets may be administered for approximately one month before initiating the first injection to assess the medicine’s tolerability.
40.1 million deaths
Since the beginning of the epidemic, 84.2 million people have been infected with the HIV virus, and about 40.1 million people have died due to the virus, according to the WHO.
Globally, 38.4 million people were living with HIV at the end of 2021. An estimated 0.7% of adults aged 15–49 years worldwide are living with HIV, although the burden of the epidemic continues to vary considerably between countries and regions.
The WHO African Region remains most severely affected, with nearly 1 in every 25 adults (3.4%) living with HIV and accounting for more than two-thirds of the people living with HIV worldwide.
