Summaries of health policy coverage from major news organizations
Abbott Files for South African Approval of New Version of Kaletra
Abbott Laboratories last week announced that the company has filed for South African approval of the new tablet form of its antiretroviral drug Kaletra, South Africa's Cape Argus reports (Caelers, Cape Argus, 4/11). FDA in October 2005 approved the new form of Kaletra that allows patients to take fewer pills, does not require refrigeration and can be taken with or without food. Kaletra is used as part of second-line antiretroviral drug treatment. According to Medecins Sans Frontieres, 6% of its patients in 2005 who had been taking antiretroviral drugs for three years needed to switch to a second-line treatment. MSF in March announced that it asked drug maker Abbott to make the tablet form of Kaletra available in developing countries. MSF -- in a letter signed by HIV/AIDS advocates, including U.N. Special Envoy for HIV/AIDS in Africa Stephen Lewis -- called on Abbott to "immediately register the drug in all countries where the older form had been registered, as well as in other developing countries" and offer it at a cost of no more than $500 per patient annually, which is the cost of the older version of the drug. The new version of Kaletra costs $9,687 per patient annually in the U.S. MSF also urged Abbott to eliminate patent barriers and permit the manufacturing of generic forms of the drug (Kaiser Daily HIV/AIDS Report, 3/17). Abbott spokesperson Melissa Brotz said that European approval is required of a drug prior to its approval in many African countries but added that South Africa has its own approval process. Brotz also said that if Kaletra is approved locally, Abbott will import the new version of the drug (Cape Argus, 4/11). According to a company release, Abbott plans to offer the drug at $500 per patient annually (Abbott Laboratories release, 4/4). European approval of the drug is expected "within months," according to the Cape Argus (Cape Argus, 4/11).
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