Novartis receives WHO nod for malaria drug Coartem
pharmafile | July 17, 2015 | News story | Manufacturing and Production | Coartem, Novartis, WHO, antimalarial, malaria, world health organization
The World Health Organization will add Novartis’ antimalarial treatment Coartem to the prequalified list of vaccines that is supplies to international aid agencies.
The prequalification makes it the first and only high strength artemisinin-based combination therapy (ACT) antimalarial treatment available for the public.
The WHO prequalification of Coartem (artemether/lumefantrine) allows the broad-scale public use of the drug, with the possibility of providing access to the treatment to as many as 25 million people across Africa.
The list of prequalified medicinal products – used for HIV/AIDS, malaria, tuberculosis and for reproductive health – is produced by the WHO and is used principally by United Nations agencies including UNAIDS and UNICEF, to guide their procurement decisions.
The Novartis Malaria Initiative has supplied more than 700 million antimalarial treatments, and the Swiss firm has two new classes of antimalarial drugs currently in Phase II clinical development.
Joseph Jimenez, chief executive of Novartis, says: “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. WHO prequalification of Coartem 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 bioequivalent to four tablets of Coartem 20/120mg, which means fewer tablets need to be taken in one course of treatment than previously, lowering the pill burden for patients.
The reduction in the number of tablets associated with Coartemcould increase convenience and overcome the challenges associated with therapies that require taking a large number of pills. Studies have shown that patient adherence to ACTs varies considerably, from 39% to 100%. Failure to complete the full treatment course makes treatment less effective and contributes to malaria parasites developing resistance to the drug.
“We welcome the arrival of high-strength Coartem,” says Dr Nafo Traoré, executive director of the 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.”
Malaria is a preventable and treatable condition which in the past has been responsible for approximately 584,000 deaths in 2013. The new dosage strength of the drug has the potential to improve malaria management.
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.
Yasmita Kumar
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