1st rectal artesunate suppository to be quality assured

If left untreated, uncomplicated malaria can quickly progress to severe malaria − a life-threatening condition that can kill within a few hours. The first point-of-care for many patients with severe malaria is a community level health-care worker or a primary care facility. Those presenting with severe malaria should be treated as quickly as possible with injectable artesunate (Inj AS), followed by oral treatment with an ACT when the patient is sufficiently well; however, most local health posts do not have the Inj AS or personnel trained in its administration. As a result, patients need to be referred to higher-level facilities, creating delays in access to critically-needed treatment. In such cases, WHO recommends the use of rectal artesunate (RAS) as a pre-referral intervention.1 RAS buys time until Inj AS can be administered – and can mean the difference between life and death.2,3

With funding from UNITAID, MMV has been working with two Indian pharmaceutical companies, Cipla and Strides Shasun, to obtain WHO prequalification for their RAS products. Both companies submitted their dossiers to the WHO Prequalification of Medicines Programme in 2015.

In 2016, the Expert Review Panel (ERP) of the Global Fund issued a 12-month authorization for procurement of Cipla’s product. The authorization allows RAS to be procured while awaiting WHO prequalification, and offers a landmark opportunity for donor financing to support broad uptake of this critically-needed medicine.

Through renewed UNITAID funding, MMV will support the registration of RAS in several high-burden African countries. In parallel, MMV will be working with implementing partners and host countries to design pilot introduction programmes for RAS. These will develop and test tool kits to help reinforce correct use of RAS and referral of patients to health-care facilities for treatment with Inj AS followed by an oral ACT. This will form part of an integrated severe malaria management approach.

Updated July 2017

1. World Health Organization. Guidelines for the treatment of malaria. Second edition (2010).

2. 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).

3. WHO-TDR website. Rectal artesunate testing and delivery (2016).