Malawi registers long-acting HIV prevention drug

The Pharmacy and Medicines Regulatory Authority (PMRA) has approved Lenacapavir, a long-acting HIV prevention medicine.

The authority describe the approval as a major step forward in the country’s efforts to reduce new HIV infections.

Health experts say its long-acting nature will significantly improve adherence and expand prevention options for people at substantial risk of HIV infection.

Lenacapavir, made by Gilead Sciences Ireland UC, is a new HIV prevention drug given as an injection twice a year to adults and adolescents weighing at least 35 kilograms.

PMRA approved the drug on November 28 after a fast review done with support from the European Medicines Agency and the World Health Organization. The application was first submitted on October 13.

PMRA Director General Mphatso Kawaye said the approval shows the authority’s commitment to quickly providing safe and effective medicines.

Kawaye said. “The expedited registration of Lenacapavir showcases PMRA’s unwavering commitment to fast-tracking access to high-quality, safe, and effective medicines.”

The drug is injected under the skin every six months, making it one of the easiest HIV prevention options available.

National AIDS Commission (NAC) CEO Beatrice Matanje said the approval is a major step forward in HIV prevention.

“Its twice-yearly administration significantly reduces dosing burden and minimizes healthcare visits, thereby improving patient convenience and supporting long-term adherence,” Matanje said

Malawi already offers daily oral PrEP and recently introduced another injectable option, Cabotegravir (CAB-LA), which is given every two months in selected pilot districts.

Health expert have expressed high expectations that the Lenacapavir will become another important tool in the country’s HIV prevention efforts as rollout expands in 2026.

PMRA and NAC are now working on plans for nationwide distribution.