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The Food and Drug Administration (FDA) announced the tentative approval of a co-package of three antiretroviral drugs used together to initiate treatment against HIV/AIDS. The regimen, consisting of lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets, is for the treatment of HIV-1 infection in adults. It is manufactured by Aurobindo Pharma Ltd. of Hyderabad, India. This is the first co-package of these products that has met the clinical safety and efficacy and the manufacturing quality standards of the FDA.
"The co-packaging of these drugs should make distribution of the drugs easier in many situations and make it easier for patients to take the right drugs in the right amount at the right time," said Murray M. Lumpkin, M.D., FDA Deputy Commissioner for International and Special Programs. "This should be particularly helpful in many of the areas of the world being especially targeted by the President's Plan, where the co-package can offer a full HIV treatment regimen for an HIV infected individual initiating therapy."
The agency's tentative approval means that although existing patents and/or exclusivity prevent approval of this product in the United States, it meets all of FDA's manufacturing quality and clinical safety and efficacy standards required for marketing in the United States. For its review of all generic applications, FDA conducts an on-site inspection of each manufacturing facility as well as the facilities performing the bioequivalence studies prior to granting approval or tentative approval in order to assess the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application. Bioequivalence studies are used to determine whether two products are equal in the rate and extent to which the active, therapeutic ingredients are absorbed and become available in the body.
Having received FDA's tentative approval, the product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
PEPFAR, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries. PEPFAR is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children. It targets three specific areas related to HIV/AIDS:
Lamivudine and zidovudine are both in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs) and efavirenz is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Both classes of drugs help keep the AIDS virus from reproducing at the same step in the AIDS virus life cycle but do so in somewhat different ways.
FDA granted tentative approval for the generic formulation of efavirenz on June 24, 2005, and for the fixed dose combination of lamivudine and zidovudine on July 7, 2005, both manufactured by Aurobindo Pharma LTD. Aurobindo Pharma's lamivudine/zidovudine fixed dose combination tablets are a version of the already FDA approved Combivir tablets manufactured by GlaxoSmithKline, and the efavirenz tablets are a version of Sustiva tablets manufactured by Bristol Myers-Squibb.
More information on HIV and AIDS is available online at FDA's website: www.fda.gov/oashi/aids/hiv.html.
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