Community Regulatory Accountability Committee (CRAC) take on LEN for HIV Prevention

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OPINION

By Ruth Akulu

On June 18, 2025, the US Food and Drug Administration (FDA) approved Lenacapavir (LEN) to be marketed as Yeztugo®, for use as a bi-annual injectable for HIV prevention, marking a significant milestone in the global HIV prevention pipeline.

LEN adds to the growing portfolio of long-acting, discreet HIV prevention options, which may be particularly transformative for young women (AGYW) and other populations at risk who need alternatives to the current methods like the monthly Dapivirine Vaginal Ring, bi-monthly injectable Cabotegravir, oral PrEP, condoms, and the forthcoming Dual Prevention Pill (DPP) to prevent HIV and unintended pregnancy co-currently.

As CRAC, we celebrate this regulatory milestone. It sends a powerful signal to regulatory authorities across Africa, including the National Drug Authority (NDA) in Uganda, to fast-track review and approval processes for LEN and similar next-generation prevention tools.

The FDA’s approval provides a strong reference dossier that can support accelerated regulatory decisions, especially once WHO Prequalification (PQ) follows. While CRAC was initially established to focus on the DPP and ensure that community voices, particularly those of AGYW, are central to regulatory conversations, it is also imperative to monitor and strengthen accountability around a broader range of emerging HIV prevention technologies, including LEN. This reflects our commitment to community-responsive, transparent, and timely regulatory processes.

CRAC was officially launched on April 30, 2025, during an orientation convened by HopeStone Insight Uganda, in collaboration with the DPP Civil Society Advisory Group and DPP Consortium. The launch brought together key national stakeholders, including the Ministry of Health, NDA, Uganda AIDS Commission, civil society organisations, HIV prevention researchers, and youth advocates, to build regulatory literacy and catalyse informed community participation in the approval and rollout of the DPP and other new prevention methods.

We urge the NDA and other regulatory authorities across Africa to proactively prepare LEN’s dossier, engage early with Gilead Sciences, the LEN manufacturer, and ensure community transparency and inclusion throughout the registration process. We also call on global partners to support knowledge-sharing, South–South collaboration, and regulatory capacity-building, ensuring that no country is left behind in accessing transformative HIV prevention tools.

In 2023, according to UNAIDS, 1.3 million people globally acquired HIV, averaging over 3,000 new infections every day. In Uganda, more than 38,000 people were newly infected with HIV, and adolescent girls and young women aged 15–24 accounted for 80% of the same age group.

Timely approval and equitable rollout of LEN can significantly reduce new HIV infections among young people, protect human capital, minimise productivity losses, and ease pressure on overstretched health systems. In countries like Uganda, where over 70% of the population is under age 30 and is vulnerable to HIV, investing in high-impact prevention tools like LEN is not only a public health imperative but also a smart economic strategy.

While the FDA’s approval of LEN marks a critical advancement in HIV prevention, its current pricing poses a major barrier to access. At a list price of up to $28,218 (sh102 million) per person per year, LEN remains unaffordable for most African governments and communities. Without proactive steps toward equitable pricing and open licensing, this innovation risks becoming yet another symbol of global health inequity.

We call upon Gilead Sciences to urgently pursue voluntary licensing agreements through the Medicines Patent Pool (MPP) to facilitate the production of affordable, quality-assured generic versions for African markets. We also urge the company to engage in differential pricing negotiations with governments and donors, aligned with the economic realities of low- and middle-income countries (LMICs).

In addition, we emphasise the need to invest in regional manufacturing capacity for HIV prevention products, including LEN, across Africa, and strengthen African generic pharmaceutical manufacturing, which will be essential for long-term supply security, price reduction, and health system autonomy.

We also urge the African Union to create enabling regulatory and trade environments for local manufacturing, global donors such as the Global Fund, and African governments to invest in technology transfer, capacity-building, and regulatory strengthening, and regional procurement mechanisms to increase bargaining power and accelerate equal access.

In light of shrinking global health funding, especially for HIV prevention, we renew our call for bold, sustained investment to achieve epidemic control. We commend the Government of Uganda for increasing its health budget allocation to sh5.87 trillion in FY 2025/26, up from sh2.95 trillion the previous year, which now represents 8.1% of the total national budget. We urge the government to allocate a portion of this increase toward procuring and introducing new HIV prevention tools like LEN and the DPP, and to ensure the approval and rollout process meaningfully integrates community voices.

True access to LEN will not be measured by FDA approval alone, but by our ability to translate innovation into affordable, timely access, and equitable prevention for communities most at risk. Together, we must ensure that no one is left behind in HIV prevention.

An Economist and Founder of HopeStone Insight Uganda