The Food and Drug Administration (FDA) has granted priority review status for Novartis AG´s Coartem (artemether 20 mg/lumefantrine 120 mg), an artemisinin-based combination treatment (ACT) for malaria.

A priority review designation will reduce the regulating agency´s review of the treatment to a six-months period.

Coartem is a fixed-dose, three-day combination of two anti-malarials, and according to studies, achieves cure rates of over 96 percent. Combining two or more malaria drugs has the potential to prevent or delay the development of resistance.

Coartem has been recommended by the World Health Organization (WHO) and is already widely used in Africa.

Dr. Daniel Vasella, chairman and CEO of Novartis, stated the company “has supplied 195 million treatments of Coartem without profit, helping to save the lives of close to 500,000 people suffering from malaria. Now Coartem has the potential to be the first ACT approved in the US."

The U.S. Agency for International Development (USAID) and the Centers for Disease Control and Prevention (CDC) employ a comprehensive approach of prevention and treatment to reduce African deaths due to malaria.

Coartem is approved in over 80 countries, including 16 in Europe. It is indicated for the treatment of acute uncomplicated infections due to plasmodium falciparum, the most dangerous form of malaria.

According to statistics, nearly 40 percent of the world´s population is at risk of contracting the disease, which is caused by a mosquito-borne parasite. Mostly in Africa, there are more than one million malaria-related deaths, mainly children.

The most frequently reported side effects in patients who take Coartem include headache, dizziness, weight loss, weakness, fatigue and nausea.