GSK opens license for HIV preventative to increase access in lower-income countries

GSK has voluntarily opened the intellectual property rights on it's long-acting injectable HIV preventative medicine to three companies, so that they can make generic versions that will be more accessible to less-developed countries. 

Following this, GSK has just announced that they have reached agreements with three companies permitting them to make generic versions of Apretude, to be distributed in lower-income countries, to help combat the HIV epidemic in these areas. 

PrEP treatments to protect at risk HIV-negative individuals have so far only been available in pill form, to be taking daily, Apretude is the first PrEP injectable option, which lasts for a much longer time between doses, which will help to increase patient adherence. 

Apretude was approved by the US FDA for GSK in December 2021. After a few months of the drug being licensed, GSK confirmed it would be working with Medicines Patent Pool, United Nations-backed healthcare organisation, to start a programme to increase access for lower income countries to new HIV therapeutics, and to get that access faster than before. 

In Africa, where the most new cases of HIV occur, medicines that were readily available in higher income countries were mostly unobtainable at the turn of the century. With this new programme, GSK are hoping to turn that around, making the longer-acting injectable more readily available on the continent by from 2026. 

ViiV Healthcare, GSK’s HIV division, confirmed that it had waived intellectual property rights by way of granting voluntary licenses to Aurobindo, Cipla, and Viatris, who will now all have the freedom to make generic versions of the injectable. 

These generic versions will be available in 90 countries, once they have passed all necessary regulatory approval locally. 

Cipla, an India-based drug maker, plans to make the injections in India, and outsource manufacturing to South Africa, in an effort to increase the manufacturing capabilities in the country, reducing the reliance on imports and therefore making medicines more accessible. The COVID-19 pandemic highlighted the need for in situ medicine manufacturing in Africa to be able to bring urgent medical care to those who need it most.