FDA Approves Two Fixed-Dose Combination Drug Products

The Food and Drug Administration (FDA) today announced the approvals of Epzicom (abacavir/lamivudine) and Truvada (tenofovir disoproxil/emtricitabine), two fixed-dose combination treatments for HIV-1 infection. Control of HIV/AIDS generally requires simultaneous use of three or more drugs from different classes. Combination products bring together different HIV/AIDS drugs in a single medication or co-package and help make treatment regimens less complicated for patients to follow.
"We gained important scientific knowledge during the development of these products that will be especially useful in our efforts to speed the availability of safe and effective fixed-dose combination products to those who need them in this country and in developing countries under President Bush's Emergency Plan for AIDS Relief program," said Dr. Lester M. Crawford, acting FDA commissioner.
"Simplifying treatment regimens by reducing the number of pills and times per day patients need to take them provides significant public health benefits," Crawford added.
Epzicom and Truvada are indicated for use in combination with other antiretroviral drug products from different classes such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors for the treatment of adults with HIV-1 infection.
Epzicom is a fixed-dose combination of the antiretroviral drugs abacavir sulfate 600mg and lamivudine 300mg, both of which are approved individually under the brand names Ziagen (abacavir sulfate) and Epivir (lamivudine). Epzicom's approval is based on a large well-controlled clinical study which showed that abacavir dosed once daily had a similar antiviral effect as abacavir dosed twice daily both in conjunction with lamivudine and with efaviranz, another antiretroviral drug.
Truvada is a fixed-dose combination of the antiretroviral drugs tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, both of which are approved individually under the brand names Viread and Emtriva, respectively. The approval of Truvada is based on data demonstrating therapeutic equivalence between the combination product and the individual products.
FDA completed its review of Epzicom in 10 months and its review of Truvada in four months. GlaxoSmithKline submitted their New Drug Application (NDA) for Epzicom in October 2003. Gilead Sciences, Inc., submitted their New Drug Application (NDA) for Truvada in March 2004.
Source: FDA