The Pharmacy and Medicines Regulatory Authority (PMRA) and the National AIDS Commission (NAC) have confirmed the approval of Lenacapavir, an HIV prevention drug, for use in Malawi.
Lenacapavir, manufactured by Gilead Sciences, is administered twice a year and is designed to protect individuals at high risk of contracting HIV.
The drug is intended for people who are HIV-negative, particularly those weighing more than 35 kilograms, and offers long-acting protection against the virus.
PMRA received the application to review Lenacapavir on 13 October this year and conducted its assessment in collaboration with the European Medicines Agency and the World Health Organization (WHO).
Following this review, PMRA granted authorisation for the drug to be rolled out in the country.
As speaking to the truth, PMRA spokesperson Mphatso Kawaye said the approval marks an important step toward strengthening HIV prevention options for Malawians.
NAC Executive Director Dr Beatrice Matanje said Lenacapavir will ease the burden on users by reducing the frequency of clinic visits, as the injection is administered only once every six months.
Malawi is currently also offering another injectable HIV prevention drug, Cabotegravir, which is provided every two months in selected districts including Lilongwe, Blantyre, Neno and Dedza.
The Ministry of Health says distribution guidelines for Lenacapavir will
