Johnson Progress

Zimbabwe’s Medicines Control Authority (MCAZ) has announced the expedited approval of Lenacapavir, a groundbreaking long-acting medicine for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection.

 

The approval, granted in just 23 days, marks a significant milestone in the country’s fight against HIV/AIDS.

 

“The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products,” said MCAZ Director-General, Mr. Richard T. Rukwata.

 

According to Mr. Rukwata, this milestone brings new hope for HIV prevention and reinforces the authority’s commitment to safeguarding public health.

 

Lenacapavir is recommended for PrEP in adults and adolescents weighing at least 35 kg, and is administered as a six-monthly subcutaneous injection following an initiation phase.

 

The medicine is intended for individuals who are HIV-negative and at substantial risk of HIV infection, and must be used alongside safer sex practices.

 

The MCAZ applied a regulatory reliance approach, drawing on scientific assessments from the World Health Organization Prequalification (WHO PQ) programme to support an efficient and robust review process.

 

This approach enabled the authority to conduct a comprehensive assessment of the product’s safety, efficacy, and quality in a remarkably short period.

 

The registration of Lenacapavir marks a significant advancement in Zimbabwe’s HIV prevention strategy, offering a long-acting alternative to daily oral PrEP.

 

This innovation has the potential to improve adherence and expand prevention options for populations most vulnerable to HIV infection.

 

MCAZ remains committed to ensuring access to high-quality, safe, and effective medical products that strengthen public health and contribute to Zimbabwe’s fight against HIV/AIDS.

 

The authority’s expedited approval process demonstrates its dedication to accelerating access to life-saving health products and protecting public health.

 

The approval of Lenacapavir is a testament to MCAZ’s commitment to regulatory excellence and its role as a leader in promoting public health in Zimbabwe.