Novartis announced that the US Food and Drug Administration (FDA) has granted priority review for Coartem® (artemether 20 mg/lumefantrine 120 mg), the leading artemisinin-based combination treatment (ACT) for malaria worldwide. Recommended by the World Health Organization (WHO) and widely used in Africa, Coartem could become the first ACT approved for use by the FDA.
Priority reviews are granted by the FDA to address urgent unmet health issues. These reduce FDA review time for new drug applications from the standard term of 10 months to just six months, and are granted to drugs offering significant advances beyond current treatments or where no adequate therapy exists.
"I am pleased that Coartem has been granted priority review by the FDA," said Dr. Daniel Vasella, chairman and CEO of Novartis. "In the fight against malaria, we have 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 US government is at the forefront of the international fight against malaria. The President's Malaria Initiative (PMI), led by the US Agency for International Development (USAID) and the Centers for Disease Control and Prevention (CDC), employs a comprehensive approach of prevention and treatment to reduce African deaths due to malaria. PMI is one of the largest purchasers of ACTs.
"ACTs play an important role in the fight against malaria," said Rear Admiral Tim Ziemer, US Malaria Coordinator. "We are pleased to learn that Novartis is seeking FDA approval for Coartem, a treatment that has already had an important impact in controlling malaria in Africa."
Nearly 40% of the world's population lives at risk of contracting malaria, which is caused by a mosquito-borne parasite. Each year there are more than one million malaria-related deaths, mostly involving children. In Africa alone, one child dies every 30 seconds from malaria.
Coartem, a fixed-dose combination of two antimalarials, is a highly-effective three-day malaria treatment that according to studies achieves cure rates of over 96% even in areas of multi-drug resistance,. Combining two or more malaria drugs has the potential to prevent or delay the development of resistance.
In a unique collaboration with international organizations, Novartis has provided more than 195 million Coartem treatments for public sector use in Africa without profit.
Currently approved in more than 80 countries, including 16 European nations, Coartem is the only fixed-dose ACT that has been approved by internationally-recognized stringent health authorities. In these countries, it is indicated for the treatment of acute uncomplicated infections due to plasmodium falciparum, the most dangerous form of malaria. The most frequently reported side effects in patients who take Coartem include headache, dizziness, weight loss, weakness, fatigue and nausea.