Malawi approves usage of HIV injectable drug

LILONGWE, Malawi

Malawi on Thursday approved the usage of the injectable HIV drug, lenacapavir, becoming the fourth African nation to authorize the medicine, a development that health experts hailed as a “major breakthrough” in the fight against soaring HIV cases in the Southeast African nation.

The drug developed by Gilead Sciences Ireland, UC, is administered through a single injection every six months.

The country’s Pharmacy and Medicines Regulatory Authority (PMRA) approved the drug following a 46-day expedited review, placing the country among the world’s earliest pioneers of the drug.

Dr. Beatrice Matanje, executive director of the country’s National AIDS Commission (NAC), hailed the approval as a “great milestone” in the fight against HIV in the country.

“This approval represents a major breakthrough in the prevention of HIV. We are actually motivated to fight on as a commission to reduce the rate of infection among Malawians,” Matanje told Anadolu.

“A twice-yearly injection significantly reduces the burden of adherence and clinic visits, and this has the potential to transform preventive outcomes,” she said.

PMRA’s Director General Mphatso Kawaye has described the approval as a “deliberate strategy to accelerate access to life-saving innovations.”

“This expedited regulation of lenacapavir showcases PMRA’s unwavering commitment to fast-tracking high-quality, safe, and effective medicines for Malawians,” Kawaye told Anadolu.

The approval has been facilitated in joint collaboration with the European Medicines Agency (EMA) and the World Health Organization (WHO), which has been instrumental in accelerating regulatory decisions across Southern Africa.

South Africa, Zambia and Zimbabwe have already approved usage of the drug.

The Global Fund, an international financing and partnership organization, has committed to supporting the country's adoption, with first consignments expected to arrive in Africa by the end of the year, according to a recent statement from the organization.

Malawi’s approval of the drug comes as the country continues to battle with soaring HIV prevalence rates, said to be among the highest in the world. About 950,000 Malawians, mostly women and children, are living with the disease, according to the National AIDS Commission.