LONDON (Reuters) - A new drug for malaria proved as effective as Novartis’s leading treatment Coartem in a clinical trial, researchers said on Friday, although an outside expert said the findings had limitations.
Coartem is the current “gold standard” for people infected with the mosquito-borne disease. The two-in-one Novartis drug needs to be taken twice a day and requires a fatty diet for optimum absorption.
Pyramax from South Korean drugmaker Shin Poong Pharmaceuticals is taken just once daily.
A randomized Phase III study of Pyramax — a fixed-dose combination of pyronaridine and artesunate — showed a treatment response of 99.5 percent compared to 99.2 percent among patients on Coartem, which combines artemether and lumefantrine.
Researchers involved in the study wrote in the Lancet medical journal that a three-day course of Pyramax should be considered for inclusion in malaria treatment programs, especially given its low cost of less than $1 for adults and 50 cents for children.
In an accompanying comment, however, Dr Francois Henri Nosten of the Mahidol-Oxford University Tropical Medicine Research Programme said a limitation of the study was that it consisted of many older African children and adults who had probably acquired some malaria immunity.
He also raised concerns about patients on Pyramax having raised liver enzymes, a possible signal of liver toxicity.
The Pyramax study was sponsored by Shin Poong and the non-profit Medicines for Malaria Venture (MMV).
MMV argues it is vital to have multiple anti-malaria drugs available to ensure innovation and guarantee competition in the marketplace, thereby driving down prices for life-saving medicines in poor countries.
Pyramax was submitted to the European Medicines Agency for regulatory approval earlier this year.
Reporting by Ben Hirschler; Editing by Michael Shields