New Malaria Drug Proves Effective in Study of African Children

A recent publication from the top medical journal The Lancet might bring a more optimistic way to treat African children who suffer from severe P. falciparum malaria.

The article introduced a large multicentre five-year clinical trial named AQUAMAT, which was an open randomised comparison of parenteral artesunate and parenteral quinine in African children with severe P. falciparum malaria in 9 African countries. AQUAMAT was sponsored by the University of Oxford and funded by The Wellcome Trust (UK).

The study was coordinated by the Mahidol-Oxford Research Unit in Bangkok. This was a large multicentre open label comparison in children admitted to hospital with severe malaria. 5425 children were enrolled to 11 centerss in 9 countries (Mozambique, The Gambia, Ghana, Kenya, Tenzania, Nigeria, Uganda, Rwanda and Democratic Republic of Congo) across Africa from October 2005 to July 2010.

The result of AQUAMAT indicated that Artesunate substantially reduces mortality in African children with severe malaria. These data, together with a meta-analysis of all trials comparing artesuante and quinine, strongly suggest that parenteral artesuante should replace quinine everywhere as the treatment of choice of severe falciparum malaria.

Prof. Nicholas J White, the lead author of this trial said that the result of the trial was exciting: Following artesunate treatment 8.5% (230/2712) of the patients died compared with 10.9% (297/2713) following quinine, an odds ratio stratified for study site of 0.75 (95%CI 0.63 to 0.90), and a relative reduction of 22.5% (95% CI 8.1 to 36.9%, p=0.0022).

IV artesunate used in AQUAMAT was manufactured by a Chinese pharmaceutical company Fosun | Guilin Pharma. Artesun, the IV artesuante product that is made by Guilin Pharma, has been launched in over 30 African countries. Artesun was introduced to African market in 2006. In the past four years, Artesun has been accepted by more and more experts, doctors and pharmacists as well as patients

In 2008 we were informed occasionally that AQUAMAT was conduced in Africa, and our product Artesun was used as the investigational drug in the trial. Since severe malaria is a major cause of childhood death and often the main reason for pediatric hospital admission in Sub-Saharan Africa, we realized that AQUAMAT might have benefit on African children, whom are the main survivors of severe malaria, by exploring for more effective treatment. Therefore, we began to supply free Artesun to AQUAMAT so as to help African children. said Ms. Su Li, VP of Fosun | Guilin Pharma.

As the innovator of IV artesuante, Guilin Pharma was authorized the Class A New Drug No. 002 by Chinese SFDA. In China, Guilin Pharma is the only pharmaceutical company that is able to produce such kind of drug. However, the absence of clinical data has hindered IV artesunate from African market. It is difficult to promote a drug without sufficient local clinical trials , said by Prof. Afolabi, an malaria expert in Nigeria.

The quality of Guilin s IV artesuante obtained positive evaluation by AQUAMAT: The content of artesunate in all ampoules tested was found to be within the pharmaceutical content limits of 10% of the stated active ingredient.

Ms. Su Li said, The AQUAMAT publication helped to enlarge the usage of IV artesuante for the treatment of severe malaria (particularly in children). We believe it will play an active role in changing the treatment policy of severe malaria in African countries. On the other hand, since Guilin Pharma is the only IV artesuante manufacturer which has been recently Pre-qualified and recommended by WHO so far, we are confident to provide sufficient quantity of quality-guaranteed Artesun to African market`.

As recommended by the publication, if four million African children with severe malaria each year were to receive prompt treatment with parenteral artesunate instead of quinine, and the benefits were similar to those observed in this trial, approximately 100,000 lives might be saved annually.