WHO prequalified Coartem® 80/480mg is the first and only high strength malaria treatment available for donor-funded public sector procurement.
Coartem® 80/480mg reduces the pill burden for patients, potentially improving adherence to treatment and clinical outcomes.
This follows the launch of the first fixed-dose ACT and the first child friendly ACT formulation, underscoring the ongoing innovation of Novartis in malaria treatment.
Novartis (http://www.novartis.com) antimalarial medicine Coartem® 80/480mg today received World Health Organization (WHO) prequalification, making it the first and only high strength (80/480mg) Artemisinin-based Combination Therapy (ACT) antimalarial treatment available for public sector procurement. This new dosage strength*, has the potential to improve malaria management. WHO prequalification of Coartem® 80/480mg 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 programs,” said Joseph Jimenez, CEO 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.”
Although preventable and treatable, malaria was responsible for approximately 584,000 deaths in 2013
(World Health Organization, Malaria. Available at: http://www.who.int/mediacentre/factsheets/fs094/en/. Date accessed: April 2015). One Coartem® 80/480mg tablet is bioequivalent to four tablets of Coartem® 20/120mg** (Lefèvre G. et al, 2013. Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem®) for bioequivalence in a randomized, open-label, two-period study. Malaria Journal, 12:(312): 1475-2875), resulting in a lower pill burden for patients – six tablets for completion of the course of treatment, compared to the previous 24. Studies have shown that patient adherence to ACTs varies considerably, from 39% to 100%
(Banek K. et al, 2014. Adherence to artemisinin-based combination therapy for the treatment of malaria: a systematic review of the evidence. Malaria Journal, 13(1): 7). 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 increase convenience and overcome the challenges associated with therapies that require taking a large number of pills, therefore improving adherence to treatment and clinical effectiveness.
“We welcome the arrival of high-strength Coartem® 80/480mg said Dr Nafo Traoré, Executive Director of Roll Back Malaria Partnership. “By reducing the number of pills that adults have to take, we hope to see better adherence to treatment regimens, helping us to combat this preventable and treatable disease which still kills hundreds of thousands of people.”
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. This latest formulation highlights the efforts of Novartis to expand access to essential malaria treatments for all ages: in 2004 Coartem® 20/120mg was the first fixed-dose ACT prequalified by the WHO and in 2009, Coartem®
Dispersible was launched as the first dispersible ACT designed specifically for infants and children. Today, more than 700 million treatments, including 250 million Coartem®
Dispersible antimalarials, have been delivered without profit to malaria-endemic countries.
* Approved for adults and children (weighing above 35 kg and older than 12 years) with uncomplicated Plasmodium falciparum (P. falciparum) malaria
** Coartem® 80/480mg is made up of 80mg artemether and 480mg lumefantrine. Coartem® 20/120mg is made up of 20mg artemether and 120mg lumefantrine