Guilin Pharmaceutical has been producing injectable artesunate for patients with severe malaria since 1987. But without WHO prequalification or stringent regulatory approval, it could not be purchased by international organizations or donor funds and was thus not reaching this vulnerable group. When approached by Guilin, MMV decided to use its R&D know-how in a more unconventional way. Instead of developing a new high-quality product from scratch the team worked with Guilin to achieve WHO prequalification for the existing medicine, enabling it to reach more of the patients that so sorely need it.
Dr Arjen Dondorp, Deputy Director and Head of Malaria Research at the Mahidol–Oxford Tropical Medicine Research Unit in Bangkok, Thailand speaks about his research, which focuses on the pathophysiology and treatment of severe malaria, and antimalarial drug resistance.
1. What’s actually happening in the body of a patient with severe malaria?
The main reason you become so ill from severe malaria is that the red blood cells harbouring the parasite become very sticky and adhere to the walls of the smallest blood vessels in all the vital organs, such as the brain, kidney and lung vasculature. This blocks normal circulation and can be fatal.
2. What is it like as a physician to treat patients with severe malaria?
It is a very grave disease, so unfortunately we often lose a patient. But if you can save a patient’s life, amazingly, you see someone who was in a deep coma completely recover in a matter of days. It is in these moments that all of your efforts are
3. You have just completed a series of trials demonstrating the superiority of injectable artesunate over injectable quinine in preventing death from severe malaria. What does this mean for patients?
Our trial (AQUAMAT), in more than 5,000 African children with severe malaria, showed that artesunate lowers mortality by 23% compared to quinine1. Our earlier trial in Asia showed that artesunate lowers mortality in adult severe malaria by 35%. From these results we can infer that by switching from injectable quinine to artesunate, hundreds of thousands of lives could be saved each year.
In Southeast Asia, IV artesunate is being used more and more and is becoming the first-line treatment.1 In Africa this is not yet the case. However, given these data, the expectation is that the WHO will change their treatment guidelines for Africa and African children – which will trigger policy change at national level.
The recent WHO prequalification of Guilin Pharmaceutical’s IV artesunate is also very timely and important. This stamp of approval is recognized by both endemic countries and donors, and so, via in-country registration, will accelerate IV artesunate’s journey to the patients who need it.
1. Dondorp AM et al. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an openlabel, randomised trial. Lancet. Nov 13; 376 (9753): 1647-57 (2010).