Novartis malaria treatment receives WHO prequalification

World Health Organization (WHO) prequalification has been awarded to Novartis' antimalarial medicine Coartem 80/480 mg, making it the first high strength artemisinin-based combination therapy (ACT) antimalarial treatment available for public sector procurement. The new dosage strength has the potential to improve malaria management.

WHO prequalification of Coartem 80/480 mg now allows for broad-scale public sector procurement, possibly providing access to the treatment to as many as 25 million malaria sufferers across Africa.

"Over the last ten years, Novartis has worked with partners to make Coartem treatments available to patients in the public sector and through donor-funded private sector programmes," said Joseph Jimenez, chief executive officer of Novartis. "WHO prequalification of Coartem 80/480mg aligns with the longstanding work of the Novartis Malaria Initiative and confirms the company's status as a leading innovator in malaria treatment."

One Coartem 80/480mg tablet is equivalent to four tablets of Coartem 20/120mg, so six tablets for the course of treatment compared with the previous 24. Studies have shown that patient adherence to ACTs varies considerably, from 39% to 100%. Failure to complete the full treatment course may reduce treatment efficacy and allow malaria parasites to develop resistance to the drug. The reduction in the number of tablets associated with Coartem 80/480mg could improve adherence to treatment and therefore clinical effectiveness.

Coartem 80/480mg, which received Swissmedic approval in November 2013, was launched in the private sector in Nigeria in late 2013 and has since been launched in more than ten African countries.