August 10, 2011 — The US Food and Drug Administration (FDA) today granted approval of Complera, a once-daily, 3-drug combination for treatment-naive HIV-infected patients.
Complera is a single tablet that contains rilpivirine (Edurant, Janssen Pharmaceuticals), a nonnucleoside reverse transcriptase inhibitor (NNRTI), and tenofovir (Viread, Gilead Sciences), and emtricitabine (Emtriva, Gilead Sciences), both nucleoside reverse transcriptase inhibitors (NRTIs).
Approval of the combination drug was based on previously conducted phase 3 randomized studies (ECHO and THRIVE) of rilpivirine, on which approval of that drug was based. No new studies were conducted for approval of Complera.
A bioequivalence study demonstrated that the triple-drug tablet achieved the same blood levels as each of the drugs administered individually.
The recommended dose of Complera is 1 tablet, containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir 300 mg, once daily, to be taken with food.
FDA issued the following cautions in announcing the drug's approval:
Labeling information will be posted soon on Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Complera is a single tablet that contains rilpivirine (Edurant, Janssen Pharmaceuticals), a nonnucleoside reverse transcriptase inhibitor (NNRTI), and tenofovir (Viread, Gilead Sciences), and emtricitabine (Emtriva, Gilead Sciences), both nucleoside reverse transcriptase inhibitors (NRTIs).
Approval of the combination drug was based on previously conducted phase 3 randomized studies (ECHO and THRIVE) of rilpivirine, on which approval of that drug was based. No new studies were conducted for approval of Complera.
A bioequivalence study demonstrated that the triple-drug tablet achieved the same blood levels as each of the drugs administered individually.
The recommended dose of Complera is 1 tablet, containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir 300 mg, once daily, to be taken with food.
FDA issued the following cautions in announcing the drug's approval:
- More patients with HIV-1 RNA levels greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared with subjects with lower HIV-1 RNA levels at the start of therapy with rilpivirine.
- The virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared with efavirenz.
- More subjects treated with rilpivirine developed lamivudine/emtricitabine-associated resistance compared with efavirenz.
- the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin
- the antimycobacterials rifabutin, rifampin, and rifapentine
- proton pump inhibitors, such as esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole
- more than a single dose of systemic dexamethasone
- St. John's wort
Labeling information will be posted soon on Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
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