Cipla’s artesunate suppository first to be quality-assured by Global Fund

16 Dec 2016

On 5 December, the Global Fund to Fight AIDS, Tuberculosis and Malaria’s Expert Review Panel (ERP) issued a 12-month authorization for procurement of Cipla’s rectal artesunate suppositories (RAS) for pre-referral management of severe malaria. The authorization allows RAS to be procured with international funding, while awaiting WHO prequalification, and marks the first globally recognized stamp of approval for this critically needed medicine.

Since 2005, when WHO first recommended the use of RAS for pre-referral management of young children with severe malaria,1 no RAS product has met international quality standards. As a result, countries have struggled with how to manage care without access to quality-assured drugs for this indication. 

WHO-preferred first-line treatment for severe malaria is injectable artesunate (Inj AS), which must be administered intravenously by well-trained healthcare workers, typically in a higher level facility such as a district hospital. However, the first point-of-care for many young patients with severe malaria is a community healthcare worker or a local health post where Inj AS is not available and healthcare workers are not qualified to administer it.

Given that severe malaria can kill within 24 hours if left untreated, and travel times to hospital can be long, a single dose of RAS can buy precious time for severely ill young children unable to take oral medicines. After this intervention, they should be referred to a facility where they can receive Inj AS.

A series of studies published today in Clinical Infectious Diseases, investigating how to improve malaria control in high-burden countries, demonstrate the feasibility of implementing RAS in remote communities in Africa, and that high compliance with referral to higher level facilities can be achieved.

“The Global Fund’s ERP decision marks a major milestone in the management of severe malaria,” said Dr David Reddy, CEO of MMV. “Administration of rectal artesunate reduces the risk of death and disability from severe malaria by approximately half,2,3 and as a result of the ERP decision, this vital drug can be made available to more vulnerable patients, helping to save more lives.”  

Beginning in 2012 with funding from UNITAID, MMV has been building on the early work of TDR, the Special Programme for Research and Training in Tropical Diseases, to develop a high-quality rectal artesunate product. In 2014, MMV then began working with Cipla, an Indian pharmaceutical company, to develop a RAS product that will meet WHO prequalification requirements. Cipla submitted their dossier to the WHO’s Prequalification Programme in 2015 and to the Global Fund ERP in 2016.

While the Prequalification Programme completes their evaluation, the Global Fund ERP has authorized the time-limited inclusion of this product on the list of malaria medicines meeting its Quality Assurance Policy. The product can now be purchased by international funding bodies.

TDR Director, John Reeder says, “This is an excellent example of the partnership approach to global health. It shows how different groups each provide value, so that together, we improve the health of the most vulnerable.”

Registration of RAS is now pending in ten malaria-endemic countries in Africa: Nigeria, Ghana, Kenya, Tanzania, Ethiopia, Uganda, Malawi, Zambia, Senegal and Cameroon. Additional countries where registration is planned in the future include: Ivory Coast, Mali, DRC, Burkina Faso, Niger and Mozambique.  

1. World Health Organization. Guidelines for the treatment of malaria. Third edition. (2015) 

2. World Health Organization. Malaria in children under five. (2016) 

3. Gomes MF et al. “Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial.” The Lancet. 373(9663):557-66 (2009.)