WHO provides first-ever approval for rectal artesunate product for malaria

World Health Organisation (WHO) has provided the first-ever prequalification for a rectal artesunate product for severe malaria.

This approval will expand access to rectal artesunate suppositories (RAS) and help save more young lives from malaria during that critical journey between a rural community setting and an appropriately equipped treatment centre.

Importantly, the approval achieved with support from MMV and funding from Unitaid, makes the Cipla product the first to receive prequalification for this indication.

The prequalification is expected to enable countries to procure life-saving RAS, thus ensuring the product’s greater uptake and distribution.

Dr David Reddy, CEO of MMV stated: “This is an important milestone. This approval from the WHO prequalification programme will expand access to RAS and help save more young lives from malaria during that critical journey between a rural community setting and an appropriately equipped treatment centre.

“Now that we have this international quality approval in place for RAS, we will continue the work with all stakeholders to support its introduction and availability into remote health settings to help save the lives of young children suffering from severe malaria.”

Severe malaria can kill within 24 hours if left untreated, and travel times to hospital can be long, particularly for children from remote rural communities.

WHO TDR’s 2009 study demonstrated that a single dose of RAS given as soon as a presumptive diagnosis of severe malaria is made can reduce by half the likelihood of disability and death in children unable to access injectable artesunate, WHO-preferred first-line treatment for severe malaria, within six hours.

Until now, no RAS product has met international quality standards, leaving countries with limited options to cope with children in need of pre-referral care.

To bridge this gap, MMV worked with Cipla to obtain WHO prequalification for their RAS 100mg products. Cipla received a temporary authorisation for one year from the Global Fund Expert Review Panel in 2016, allowing its product to be procured with donor funds.

Unitaid’s Executive Director, Lelio Marmora said: “We now have a formidable weapon in our armoury that has the potential, once fully deployed, to sharply reduce the number of children under five succumbing to severe malaria.”

Malaria places a heavy burden on the health of children. With intensive global effort, it is estimated that 6.2 million deaths due to malaria were prevented between 2001 and 2015; 5.9 million (95 per cent) of which were those of young children.

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