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Glaxo pulls malaria drugs due to anaemia risk
Feb 29, 08 FDA warnings Medical Product Safety AlertsGlaxoSmithKline Plc is scrapping two malaria drugs that may cause anaemia, dealing a blow to the global fight against the killer disease.
Europe’s biggest drugmaker said on Friday it was pulling Lapdap from the market in Kenya—the only place where it has recently been sold—and stopping development of a second experimental compound called Dacart.
Both medicines have been linked to reductions in haemoglobin levels in patients with a hereditary enzyme disorder that affects 10 to 25 percent of Africans. Low haemoglobin can lead to anaemia which in severe cases may require a blood transfusion.
Glaxo had been working on Dacart with the non-profit organisation Medicines for Malaria Venture and would have sold the product at concessionary prices had it been successful, so the setback is not significant commercially for the British-based group.
But it is a blow for malaria researchers, who had hoped Dacart would prove an effective new option in treating the mosquito-borne disease that kills more than a million people a year, mostly young children and pregnant women.
Dacart is an artemisinin-based combination therapy, similar to Novartis AG’s Coartem, which is currently the gold standard in malaria care.
It consists of the older drug Lapdap plus an artesunate, as recommended by the World Health Organisation, to stop the spread of drug resistance among malaria parasites.
Dr Arata Kochi, director of the WHO’s global malaria programme, said there was a critical need for new medicines but Glaxo had acted responsibly in pulling Lapdap and discontinuing any further development of drugs based on the compound.
Dacart had been in final phase III clinical tests and had appeared as effective as Coartem, so the side-effect problem was particularly disappointing.
Lapdap was never a big success because it lacked the artesunate ingredient that experts now consider vital.
Medicines for Malaria Venture spokeswoman Anna Wang said it was important to have multiple anti-malaria drugs available, to ensure innovation and guarantee competition in the marketplace, which should drive down prices further.
“We would never be satisfied with having just one diabetes or cancer drug, so we shouldn’t be satisfied with one anti-malarial,” she said.
Other products are in development in separate joint ventures with the non-profit organisation, including new artemisinin combination therapy drugs from Italy’s Sigma-Tau and South Korea’s Shin Poong Pharmaceutical, Wang added.
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