Daijiworld Media Network - Brussels

Brussels, Jul 26: In a major breakthrough in the fight against HIV, the European Medicines Agency (EMA) has recommended the approval of lenacapavir, a twice-yearly injectable drug developed by Gilead Sciences and marketed in Europe under the name Yeytuo.

The EMA, in its statement, said the injectable has proven to be “highly effective” and termed it a “major public health interest.” Once cleared by the European Commission, lenacapavir will be authorised across the 27 European Union member states, as well as Iceland, Norway and Liechtenstein.

The drug, which has already been used in HIV treatment, was found to be nearly 100% effective in preventing transmission in men and women during recent studies. Its six-month protection makes it the longest-lasting HIV prevention option, compared to existing daily oral pills and the bi-monthly injectable cabotegravir.

Health experts say the new injectable could significantly reduce stigma around daily medication and help prevent new HIV infections among high-risk groups.

UNAIDS Executive Director Winnie Byanyima said lenacapavir “could change the trajectory of the HIV epidemic,” urging global leaders to ensure wide access to the drug.

Earlier this year, the US FDA had cleared lenacapavir for HIV prevention, and the World Health Organization has also recommended its rollout as an additional preventive measure.

Meanwhile, concerns have been raised over Gilead’s licensing policy. While the company has allowed cheap generic versions in 120 low-income countries, most of Latin America has been excluded, despite a recent rise in HIV cases there.

With over 630,000 AIDS-related deaths in the past year and more than 40 million people living with HIV globally, health advocates insist equitable access to this breakthrough drug is essential to ending the epidemic.