European Medicines Agency recommends the approval of malaria vaccine

The European Medicines Agency’s Committee for Medicinal Products for Human Use recently recommended the approval of Eurartesim to treat uncomplicated Plasmodium falciparum malaria.

Eurartesim was developed by the privately-held Italian pharmaceutical company Sigma Tau Industrie Farmaceutiche Riunite for use in adults and children over the age of six months or those weighing five kilograms or more. It is a fixed combination product that is made of dihydroartemisinin and piperaquine phosphate, according to

In the European Union, the drug is being recommended for approval as an orphan medicine because of the limited number of patients in the region. Malaria is a rare disease in the E.U., affecting one out of every 33,000 people.

The orphan medicine framework was established to provide pharmaceutical companies with an incentive to develop medicines for diseases that would be neglected under normal market conditions. The drug’s status will be reviewed the next time the Committee for Orphan Medicinal Products meets, according to the Wall Street Journal.

Although a rare disease in Europe, malaria is prevalent in over 100 countries and affects half of the world’s population. The World Health Organization estimates that malaria was responsible for approximately 800,000 deaths in 2009, the majority of them among children in Africa.