Indian pharma companies sign agreement to produce and sell generic HIV drug Lenacapavir
Indian pharmaceutical companies are set to produce a generic version of HIV prevention drug, lencapavir, under a deal with US-based Gilead Sciences to distribute it in 120 resource-limited countries.
Indian pharmaceutical giants, including Dr. Reddy’s Laboratories and Emcure Pharmaceuticals, along with Gilead Sciences, Inc. are going to produce generic version of HIV prevention drug, Lencapavir, following non-exclusive licensing agreements signed with.
According to Gilead’s official statement, these agreements will allow the companies to manufacture and distribute lencapavir in 120 resource-limited countries, pending regulatory approval.
The agreements aim to accelerate access to the drug in countries with high HIV incidence, particularly low- and lower-middle-income countries.
Lencapavir, which is currently being investigated for pre-exposure prophylaxis (PrEP), is expected to revolutionize HIV prevention if approved. It has been approved by the US Food and Drug Administration (FDA) and is used to treat HIV in adults. It is being investigated in HIV prevention.
Gilead’s collaboration with pharmaceutical companies around the world, including Eva Pharma, Ferozsons Laboratories Ltd., Hetero and Viatris subsidiary Mylan, ensures that once approved, generic versions of the drug will be available quickly and at a lower price. But will be made available at a higher level. Requirement areas in 120 countries including India.
“Given the transformative potential of lencapavir for prevention, our focus is on making it available as quickly and widely as possible where it is needed most,” said Daniel O’Day, Gilead’s chairman and chief executive officer.
Earlier this year, two pivotal Phase 3 trials of lencapavir as a preventive HIV treatment, named Objective 1 and Objective 2, concluded ahead of schedule due to achieving their primary efficacy targets.
These trials showed that lencapavir taken twice a year outperformed daily oral Truvada in reducing HIV incidence.
Objective 1 included cisgender women in South Africa and Uganda, while Objective 2 focused on cisgender men, transgender individuals, and non-binary people in several countries, including Argentina, Brazil, and the United States.
Participants in these studies may continue to use lencapavir after the trial.
In addition to HIV prevention, the drug is being explored for treatment in individuals with multi-drug-resistant HIV, adding to its potential efficacy.
There is currently no cure for HIV or AIDS.
