NAIROBI, Kenya — Kenya has approved the use of a new long-acting HIV prevention injection, marking a major regulatory and public health milestone as the country intensifies efforts to curb new infections and improve access to modern prevention technologies.
In a statement issued on Saturday, January 10, Health Cabinet Secretary Aden Duale said the Ministry of Health, through the Pharmacy and Poisons Board (PPB), had recommended the registration of Lenacapavir for HIV pre-exposure prophylaxis (PrEP).
“The Ministry of Health, through the Pharmacy and Poisons Board, has recommended the registration of Lenacapavir 300 mg tablets and Lenacapavir 464 mg solution for injection, a long-acting antiretroviral medicine for HIV pre-exposure prophylaxis,” Duale said.
He said the approval followed an extensive scientific and regulatory review process that met both Kenyan legal requirements and international standards.
“This recommendation follows a comprehensive scientific assessment of the quality, safety, and efficacy of Lenacapavir, conducted in line with Kenyan law and applicable international regulatory standards,” the statement said.
Duale said Kenya’s decision places the country among the first in Africa to clear the new drug for use, reflecting alignment with global health guidance and strengthening Kenya’s position as a regional regulatory leader.
“Kenya is among the first African countries to recommend Lenacapavir for registration, a decision that aligns with recent global public health guidance, including recommendations by the World Health Organization, and reflects the country’s growing regulatory capacity and leadership in enabling timely access to innovative health technologies of public health importance,” he said.
Lenacapavir works by targeting key stages in the HIV lifecycle, preventing infection before the virus can establish itself in the body. Unlike daily oral PrEP pills, the drug is administered only twice a year, a feature the Ministry says could significantly improve adherence.
“Lenacapavir works by interfering with critical stages of the human immunodeficiency virus (HIV) lifecycle, thereby preventing HIV infection. Its long-acting formulation allows it to be administered only twice a year, offering an important alternative to daily oral HIV prevention medicines,” Duale said.
The Cabinet Secretary acknowledged that while Kenya has expanded daily oral PrEP across all 47 counties, adherence remains a challenge for some users due to pill fatigue, stigma and lifestyle factors.
“Long-acting injectable prevention options like Lenacapavir have the potential to address these challenges by reducing how often medicine needs to be taken and broadening access to effective HIV prevention,” he said.
Kenya has also been selected as a priority country for the initial global rollout of Lenacapavir, with government and international partners already planning for its introduction among populations at high risk of HIV infection.
“Kenya has been prioritised for the initial rollout of Lenacapavir through global partnerships, and preparatory planning is underway to ensure the medicine is introduced in a timely, equitable, and responsible manner,” Duale said.
The approval comes as regulators tighten oversight of Kenya’s pharmaceutical market.
In December, the PPB warned manufacturers, importers, retailers, and online sellers against dealing in unregistered, falsified, or counterfeit health products, saying such practices violate the law.
The Board said supermarkets, cosmetic shops, and general retail outlets are not authorised to stock or sell prescription-only medicines, and warned that violators face prosecution, licence revocation, and closure of premises.
