HARARE – Zimbabwe has fast-tracked approval of the new long-acting HIV prevention drug lenacapavir, clearing the injectable medicine in just 23 days, the Medicines Control Authority of Zimbabwe (MCAZ) announced on Friday.

The drug — a twice-yearly pre-exposure prophylaxis (PrEP) option — is considered a major breakthrough in the global HIV response. MCAZ said the application, submitted by United States company Gilead Sciences on October 29, underwent an expedited but rigorous review because of its significant public health importance.

MCAZ Director-General Richard T. Rukwata said the approval demonstrated the regulator’s commitment to accelerating access to essential medicines.

“The rapid approval of lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products. This milestone brings new hope for HIV prevention,” he said.

Lenacapavir is recommended for HIV-negative adults and adolescents weighing at least 35kg, and is administered as a subcutaneous injection every six months following a short initiation phase. It must be used alongside safer-sex practices such as condom use and behavioural risk-reduction measures.

MCAZ said it relied on scientific assessments from the World Health Organization’s Prequalification Programme to support its evaluation.

Zimbabwe’s approval comes as the U.S. government and Gilead Sciences begin rolling out lenacapavir in African countries, with the first shipments delivered last week to Eswatini and Zambia. Each country received about 500 starter doses.

The rollout is viewed as a turning point in widening access to long-acting HIV prevention in sub-Saharan Africa, which accounts for nearly two-thirds of all people living with HIV globally.

Daniel O’Day, Gilead’s Chairman and CEO, said collaboration with the Global Fund, PEPFAR and African governments is enabling unprecedented early access.

“For the first time, a new HIV medicine is reaching communities in sub-Saharan Africa in the same year as its U.S. approval,” O’Day said.

Regulatory submissions are currently underway in Rwanda, Tanzania, Botswana and several other high-burden countries. The programme aims to reach 18 countries covering about 70% of the region’s HIV burden by the end of 2025.

Global Fund Executive Director Peter Sands described lenacapavir as “transformational,” saying impact will depend on quickly reaching the most at-risk populations.

To boost supply, Gilead has signed royalty-free agreements with six generic manufacturers, allowing up to two million people in low-income, high-incidence countries to access the drug at no profit under Global Fund and PEPFAR support.

A senior U.S. official, Jeremy Lewin, said the rollout forms part of the America First Global Health Strategy, which backs targeted investments to reduce the global HIV burden.

Zimbabwe, officials said, is among the countries that have already made strong progress in developing a national introduction plan in coordination with PEPFAR and the Global Fund.

Lenacapavir’s twice-yearly dosing is expected to improve adherence and appeal to populations that struggle with daily PrEP. Governments are preparing public education campaigns and health-worker training to support safe delivery of the injectable.