Malawi on Thursday, December 4, authorised the use of the injectable HIV prevention drug lenacapavir, becoming the fourth African nation to approve the medication.
Health experts have described the development as a major breakthrough in efforts to curb rising HIV cases in the country. The drug, developed by Gilead Sciences Ireland, is administered once every six months. Malawi’s Pharmacy and Medicines Regulatory Authority (PMRA) granted approval following a 46-day expedited review, placing the country among the earliest adopters globally.
Dr Beatrice Matanje, executive director of the National AIDS Commission, welcomed the approval as a significant milestone, noting that a twice-yearly injection would ease the burden of adherence and clinic visits, with the potential to transform prevention outcomes.
PMRA Director General Mphatso Kawaye described the decision as part of a deliberate strategy to accelerate access to life-saving medical innovations.
The approval process was supported through collaboration with the European Medicines Agency and the World Health Organization, which have been central to speeding up regulatory decisions in Southern Africa. South Africa, Zambia and Zimbabwe have previously authorised the drug.
The Global Fund has pledged support for Malawi’s rollout, with the first consignments expected to reach Africa by the end of the year. Malawi continues to face high HIV prevalence rates, with around 950,000 people—mainly women and children—living with the virus, according to the National AIDS Commission.