WHO ultimatum on artemisinin monotherapy is showing results

The three month ultimatum to the pharmaceutical industry to stop selling the single dose form of the malaria drug artemisinin has started producing results, the World Health Organization has said. It announced last week that 13 out of 40 manufacturers of oral artemisinin monotherapies have agreed to comply with its recommendation to phase out the single drug oral treatment and to focus instead on artemisinin combination therapies (ACTs). The ultimatum was issued in January by Arata Kochi, director of the WHO Global Malaria Programme.

Artemisinin is about 90% effective in curing uncomplicated malaria and therefore in high demand. The widespread use of artemisinin monotherapy, which is easier and less expensive to produce and market than ACTs, however, hastens the development of resistance to artemisinin in malaria parasites. But when artemisinin is used in combination with other antimalarial drugs for treatment of uncomplicated malaria, the parasite is highly unlikely to become drug resistant.

“So far, no treatment failures due to artemisinin drug resistance have been documented, but we are watching the situation very attentively,” said Dr Kochi, when he launched the ultimatum in January. “We are concerned about decreased sensitivity to the drug in South-East Asia, which is the region that has traditionally been the birthplace of antimalarial drug resistance.”

The 13 companies who have said they will comply with the WHO guidance include the main producers of high quality artemisinin monotherapies, such as Paris based Sanofi-Aventis and other less well known companies from Europe and Asia. Other companies have said they are willing to collaborate with WHO, and WHO has said that it will continue to closely monitor those companies that have not yet declared their position.

In addition, the organisation said that it will provide guidance to companies manufacturing ACTs that are seeking prequalification of their products and that it will support exclusive procurement of quality ACTs for treatment of uncomplicated malaria.

As national governments have a critical part to play to eliminate demand for single drug artemisinin, WHO also called on national drug regulatory authorities in malaria endemic countries to prohibit marketing of oral artemisinin monotherapies.

Of the 76 countries that need ACTs, in January 65 were still allowing marketing of oral artemisinin monotherapy for treatment of uncomplicated malaria. Since then, 13 of those countries have announced that they will withdraw marketing authorisation for these drugs and three countries (Benin, Gabon, and Komores) have already started undertaking regulatory measures to do so.

Dr Kochi commented: “We are monitoring the situation closely, and we will work with authorities and health professionals in countries to support the use of quality ACTs in line with the WHO guidelines.”

“We applaud WHO's leadership in seeking to ban artemisinin monotherapies. Now it will be up to the manufactures as well as the regulators and leaders in effected communities to turn this crucial stipulation into reality” says Anna Wang, Vice-President Public Affairs of the Geneva-based Medicines for Malaria Venture.