Malawi has approved the injectable HIV drug lenacapavir, becoming the fourth African nation to authorise the twice-yearly medicine.
Health officials say the decision marks a significant step in a country struggling with persistently high HIV infection rates.
The drug, developed by Gilead Sciences, is administered through a single injection every six months.
The Pharmacy and Medicines Regulatory Authority endorsed the treatment after a 46-day fast-track review, placing Malawi among the earliest global adopters.
National AIDS Commission head Dr Beatrice Matanje called the approval a milestone that renews efforts to slow the spread of HIV.
She said the reduced need for clinic visits could transform prevention outcomes for vulnerable communities.
PMRA Director General Mphatso Kawaye said the expedited approval reflected a deliberate push to increase access to life-saving medicines.
He added that the move underscored the regulator’s commitment to ensuring Malawians receive safe and effective treatments without delay.
The approval process was supported by the European Medicines Agency and the World Health Organization to help speed regulatory decisions across the region.
South Africa, Zambia and Zimbabwe have already authorised the drug, creating momentum for wider African rollout.
The Global Fund has pledged financial support for Malawi’s adoption of the injectable, with first deliveries expected before the end of the year.
The decision comes as Malawi confronts one of the world’s highest HIV prevalence rates, disproportionately affecting women and children.
The National AIDS Commission estimates that roughly 950,000 Malawians are currently living with the virus.
