Pharmaceutical companies to stop manufacture of single artemisinin drug

By Henry Neondo

The World Health Organization (WHO) announced Friday that 13 pharmaceutical companies have agreed to comply with WHO's recommendation to phase out single-drug artemisinin medicines for oral treatment of malaria.

This group includes the main producers of high quality artemisinin monotherapies. The companies will now focus their marketing efforts for malaria primarily on Artemisinin Combination Therapies (ACTs), in line with WHO recommendations.

The use of single-drug artemisinin treatment, or monotherapy - especially on a wide scale for the treatment of uncomplicated malaria - hastens development of resistance to artemisinin in malaria parasites.

When used correctly in combination with other anti-malarial drugs in ACTs, artemisinin is nearly 95 percent effective in curing uncomplicated malaria and the parasite is highly unlikely to become drug resistant.

In January 2006, WHO had appealed to all companies to stop marketing oral artemisinin monotherapies and to re-direct their production efforts towards ACTs.
Following the January appeal, an additional 23 companies were identified and informed of WHO's recommendation. 13 companies said they would comply with the WHO guidance. Additional companies have said they are willing to collaborate with WHO in this endeavour.

"In the last three months, thanks to determined follow-up, we have seen significant progress towards curbing the supply of inappropriate and clinically unsound malaria treatments," said Dr LEE Jong-wook, WHO Director-General.

"WHO now calls for a complete transition to provision of WHO-recommended combination therapies, in order to preserve the efficacy of these life-saving treatments."
WHO will continue to closely monitor those companies that have not yet declared their position. In addition, the Organization will provide guidance to companies manufacturing ACTs that are seeking prequalification of their products, a process which involves meeting internationally agreed standards of efficacy, safety and quality. WHO will support exclusive procurement of quality ACTs for treatment of uncomplicated malaria.

WHO has also called on national drug regulatory authorities in malaria-endemic countries to prohibit marketing of oral artemisinin monotherapies.
So far, since January 2006, 13 countries have announced that they will withdraw marketing authorization for these drugs, and three have started undertaking regulatory measures to do so.

"To eliminate demand for single-drug artemisinin pills, national governments have a critical role to play," said Dr Arata Kochi, director of the WHO Global Malaria Programme. "We are monitoring this 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."

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