Treatment for severe malaria

With MMV’s help Guilin Pharmaceutical has become the first company to receive WHO prequalification for artesunate injection, a life-saving treatment for severe malaria.

Guilin Pharmaceutical has been producing artesunate for injection since 1987. But without WHO prequalification or stringent regulatory approval, it could not be purchased by international organizations or with donor funds and was thus not reaching patients with severe malaria. 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.

Severe malaria is the condition that rapidly ensues if a bout of uncomplicated malaria is not promptly treated. Children are particularly vulnerable since they have little or no immunity with which to fend off the parasite. The symptoms include coma, severe breathing difficulties, low blood sugar and severe anaemia, which if untreated, can lead to death.

A recent trial lead by Prof.  Nick White and colleagues has demonstrated that compared with quinine, artesunate reduced the mortality rate from 10.9% to 8.5% – a relative reduction of 22.5%. In response to these important data the WHO quickly updated their guidelines to recommend artesunate injection as first-line treatment for severe malaria in African children.

With WHO prequalification in hand, Guilin’s artesunate for injection can now be included in disease-endemic country treatment policies and be purchased with donor money. This means it has the potential to reach many more patients and save many more lives. Many malaria-endemic countries still use injectable quinine as first-line treatment for severe malaria, but given WHO approval and the recent data demonstrating superiority of artesunate over quinine, they are beginning to reconsider their malaria protocols.

November 2010