Aurobindo Pharma to manufacture, supply long-acting HIV treatment drug

Hyderabad-based Aurobindo Pharma has been selected as one of the generic manufacturers under the expanded voluntary licensing agreement between the Medicines Patent Pool (MPP) and ViiV Healthcare, global specialist HIV company majority owned by GSK, to manufacture and supply the long-acting injectable HIV treatment cabotegravir across 133 countries.

ViiV Healthcare, which has Pfizer and Shionogi as shareholders, and the Medicines Patent Pool, announced an update to their voluntary licensing agreement to include patents relating to its use in a long-acting regimen. The announcement follows updated guidance from the WHO recommending long-acting injectable cabotegravir + rilpivirine as an HIV treatment option. 

This update now includes long-acting cabotegravir (CAB LA) for HIV treatment, in addition to its earlier use for prevention only.

Aurobindo Pharma says this enables it to manufacture and supply the long-acting injectable HIV treatment across 133 countries, including several low and middle-income markets. The treatment offers an alternative to daily pills, allowing patients to receive just one injection every one or two months.

K Nithyananda Reddy, vice-chairman & managing director, Aurobindo Pharma, says, “We are privileged to be part of the sub-license expansion from MPP and ViiV to develop, manufacture, and distribute generic CAB LA in select markets for the treatment of HIV-1, in addition to the voluntary licence for PrEP. This is a significant and timely step towards increasing access to advanced long-acting treatment in LMICs.”

Aurobindo Pharma, he says, remains committed to leveraging its global supply capabilities to make this vital combination long-acting injection therapy widely available and affordable. “The consideration by ViiV and MPP to include the private market in royalty-bearing countries is a critical step toward expanding access across both public and private sectors.”

A global release by ViiV also says existing generic licensees for prevention will be able to develop, manufacture and supply generic  CAB LA, for use in combination with long-acting rilpivirine, subject to required regulatory approvals,  to help enable access to the long-acting treatment in 133 countries worldwide.

This includes all least-developed, low-income, lower-middle-income, and Sub-Saharan African countries, as well as countries where ViiV does not have patent rights for cabotegravir.

Deborah Waterhouse, CEO at ViiV Healthcare said, “As leaders in long-acting innovation, we’re proud to be expanding our voluntary licence with the MPP to now include treatment of HIV in addition to prevention. Long-acting injectables have the potential to transform HIV treatment and we welcome the latest recommendations from WHO to expand treatment options. In line with our  mission to ensure no one living with HIV is left behind, we’re committed to working with partners  like the MPP to continue to increase access and reach those most impacted by HIV.”  

Charles Gore, executive director MPP said, “We’re delighted to extend the CAB LA licence to cover treatment, reflecting the latest WHO recommendations. Our dolutegravir licence with ViiV has already enabled the supply of generic DTG-based HIV treatments in 129 countries and we hope that over time a similar coverage can be achieved for CAB LA. CAB LA is a vital additional tool in the HIV  treatment toolbox—especially for people facing adherence challenges with oral regimens. Expanding access to long-acting options like this supports a more person-centered, choice- and  needs-driven approach, which is exactly what an equitable and effective HIV response requires.” 

Meg Doherty, director global HIV, hepatitis and STI programs said, “The World Health  Organization welcomes the expansion of the voluntary licence agreement for long-acting cabotegravir to include HIV treatment. This step is closely aligned with WHO’s new recommendation of long-acting injectable antiretrovirals as an alternative for people who are virologically suppressed but face adherence challenges with daily oral regimens. It reflects our commitment to expanding access to innovative, person-centered treatment options that improve outcomes—particularly in underserved regions. This agreement aligns with our global goals to ensure equitable access to essential medicines and improve health outcomes for all. We are committed to supporting countries in implementing these new guidelines and ensuring that no one is left behind.” 

Philippe Duneton, executive director of Unitaid said, “Expanding access to long-acting injectable cabotegravir for HIV treatment is a major milestone in the global HIV response. This updated licensing agreement is a crucial step toward making innovative treatment options more accessible to people in countries most affected by HIV. Long-acting regimens can be transformative for people  who face challenges with taking daily medication, and this progress reflects the power of strong  partnerships to drive equitable access and advance our shared goal of ending the HIV epidemic.” 

The updated MPP-ViiV agreement is an extension of the voluntary licensing agreement for cabotegravir long-acting (CAB LA) for HIV pre-exposure prophylaxis (PrEP). ViiV Healthcare has been supporting the generic manufacturers with technical know-how to enable development and access to CAB LA as soon as possible. 

Through the agreement, the existing licensees, Aurobindo, Cipla and Viatris, will be able to develop, manufacture and supply generic versions of CAB LA, for use in combination with long-acting rilpivirine, for the treatment of HIV-1 infection in adults and adolescents weighing at least 35kg, subject to required regulatory approvals being obtained.