MCAZ Approves Six-Monthly HIV Prevention Injection Lenacapavir After Fast-Track Review

The Medicines Control Authority of Zimbabwe (MCAZ) has given the green light to Lenacapavir, a long-acting HIV prevention medicine, after completing an accelerated review that lasted just 23 days.

The approval was granted on November 22, following Gilead Sciences’ submission of the application on October 29.

MCAZ Director-General Richard Rukwata said that although the evaluation was concluded swiftly, the drug was subjected to a thorough scientific review.

He emphasized that Lenacapavir was prioritized due to its major public health relevance.

“Our rapid authorization of Lenacapavir demonstrates MCAZ’s commitment to speeding up access to safe and effective health products,” Rukwata said.

Lenacapavir is considered a major advancement in HIV prevention because it is administered via injection once every six months.

This biannual dosing offers an alternative to daily oral PrEP, making it especially useful for people who struggle with consistent pill-taking.

With regulatory approval now secured, health officials are expected to begin preparations for distributing the long-acting injection and integrating it into HIV prevention programs across the country.