Brussels (Brussels Morning Newspaper) – On Tuesday, Gilead Sciences announced that the European Commission approved its semi-annual injection to prevent HIV infection, according to Reuters.
Greenlight from the EU Commission applies in the EU’s 27 member states as well as Norway, Iceland, and Liechtenstein. Before the drug can be delivered to patients, Gilead will have to negotiate pricing and reimbursement arrangements with health systems in each country.
Why did the European Commission approve Gilead’s HIV injection?
The European Commission authorised the use of the drug as pre-exposure prophylaxis (PrEP) to lower the risk of sexually-acquired HIV in adults and adolescents at heightened risk of infection. Gilead stated that its EU application was evaluated on an accelerated schedule and received an extra year of market protection.
The medicine, scientifically called lenacapavir, will be available in Europe as Yeytuo. It received approval in June from US regulators, where it is marketed under a different name, Yeztugo.In the US, Gilead’s list price for Yeztugo exceeds $28,000 annually. According to LSEG, analysts forecast that the drug will generate more than $4 billion in annual sales by 2029.
How effective was lenacapavir in large-scale hiv prevention trials?
Lenacapavir showed nearly full effectiveness in preventing HIV in last year’s global trials, offering fresh hope to halt the transmission of a virus that infects 1.3 million new people every year. In July, the World Health Organisation recommended lenacapavir to be considered as an option for HIV prevention through PrEP.
In which countries has Gilead already submitted regulatory applications?
The Company announced that it has submitted an application and has submitted applications for regulatory approval for twice-yearly lenacapavir for PrEP in Australia, Brazil, Canada, South Africa, and Switzerland, and is preparing submissions in Argentina, Mexico, and Peru.
How is Gilead expanding access in low- and middle-income nations?
Gilead also said it intends to submit regulatory applications in low- and middle-income countries, including priority registrations in 18 countries accounting for 70% of the HIV burden across the 120 countries covered by its voluntary licensing agreements.
Gilead is working with the Global Fund to Fight AIDS, Tuberculosis, and Malaria to provide lenacapavir to as many as two million people in low-income countries over a three-year period, which will be achievable as generic drug manufacturers are about to begin expanding production under royalty-free terms.
