WHO pre-qualifies the first artesunate suppositories for malaria

TDR news item
27 February 2018

A life-saving treatment for the management of severe malaria in young children has been added to the World Health Organization’s prequalification list. This completes the final stage of international oversight to the quality and safety for 100 mg rectal artesunate suppositories (RAS).

Children in Tanzania during TDR study on rectal artesunate
Children in Tanzania during TDR study on rectal artesunate
WHO/TDR/Andy Craggs

The medication is manufactured by Cipla Ltd, a global pharmaceutical company based in India. It was initially developed by TDR, with further support by Medicines for Malaria Venture (MMV) and UNITAID.

TDR Director John Reeder says, “This has been an excellent example of partnerships and building excellent capacity in a low-income country to carry on the manufacturing of this needed treatment.”

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. In 2005, WHO first recommended the use of RAS for pre-referral management of young children with severe malaria. Since then, no RAS product has met international quality standards. As a result, countries have not been able to access quality-assured RAS drugs for pre-referral management of severe malaria.

TDR’s 2009 study demonstrated that a single dose of RAS 100mg, given as soon as a presumptive diagnosis of severe malaria has been made, can halve the likelihood of disability and death for young patients unable to access WHO-preferred first-line treatment for severe malaria, injectable artesunate (Inj AS), within 6 hours. After receiving RAS, patients should be referred to a facility where they can receive Inj AS to treat their malaria infection.

After this research, MMV worked with Cipla to obtain WHO prequalification for their RAS 100mg product. Umang Vohra, MD and Global CEO Cipla Ltd. said, “Cipla is committed to providing access to affordable medicines. Our endeavour is to make RAS 100 mg available in rural areas in Africa and to national community health programmes, notably with the support of international donors that have already pledged to procure rectal artesunate.”

About WHO prequalification

The WHO prequalification team assesses information submitted in support of finished pharmaceutical products or active pharmaceutical ingredients to determine whether they meet the requirements and standards for WHO prequalification.

The assessment ensured that RAS is:

  • supported with information that demonstrates that it meets international standards of quality, safety and efficacy;
  • manufactured and controlled to consistently meet acceptable standards;
  • of an acceptable quality, safety and efficacy when stored and used in accordance with appropriate instructions for use.

TDR Director John Reeder says, “We look forward to seeing this research-based innovation now leading to life saving treatment in remote populations.”

For more information, contact Dr Piero Olliaro.