Tibotec seeks FDA approval for HIV drug
06 Feb 2009
Tibotec is seeking approval from the US Food and Drug Administration (FDA) for its HIV treatment, Intelence.
It has submitted an application for the non-nucleoside reverse transcriptase inhibitor (NNRTI) tablets based on data from its phase-three studies of the drug, when used in combination with other antiretroviral agents.
Patients in the trials had already received treatment for HIV-1 and had showed resistance to NNRTIs and protease inhibitors.
Clinical trials revealed that the drug has a potentially life-threatening side-effect, however, as a very small minority of sufferers developed skin reactions, including Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema multiforme.
The company, a subsidiary of Johnson and Johnson, is presenting the data at the 15th Conference on Retroviruses and Opportunistic Infections in Boston on February 7th.
Earlier this week, Tibotec received approval from the European Commission for its HIV medication Prezista, allowing the drug to be used by patients who have not had prior treatment for the virus as part of a combination therapy.
