BMS announces marketing authorisation application submitted in Europe for atazanavir

Bristol-Myers Squibb has announced the submission of a Marketing Authorization Application to the European Medicines Evaluation Agency for atazanavir, a novel protease inhibitor under investigation for the treatment of HIV.

Atazanavir, which is currently in phase III clinical development, is a viral protease inhibitor of HIV-1 belonging to the azapeptide class and is the first protease inhibitor with data to support the potential for once-daily administration. Atazanavir has been studied in an extensive programme of clinical trials. To date, more than 1,500 patients — covering the full spectrum of HIV infection — have received atazanavir in clinical trials.

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BMS has started enrolling patients in an early access programme (EAP) in the United States to provide atazanavir to eligible patients who are in need of an investigational antiretroviral agent. A similar programme for Europe is not expected to get approval to start enrolling until early this Autumn.

Atazanavir is in the late stage of clinical development. The initial phase of the programme will provide atazanavir to patients who need it and meet specified entry criteria. As BMS compiles safety data from its ongoing phase III clinical trials, the EAP and data on interactions between atazanavir and other drugs, the company expects to modify some of the protocol restrictions that currently apply. This could allow a greater number of patients to access atazanavir.

The initial stage of the EAP will provide atazanavir to patients who are failing their current antiretroviral therapy (defined as an HIV RNA level > 5000 copies/ml and an absolute CD4 cell count of < 300 cells/mm3) and who are in need of atazanavir in order to construct a viable alternative treatment regimen. This stage of the program will also provide atazanavir to patients who have severe HAART-associated hyperlipidemia despite lipid lowering therapy, defined as a triglyceride level > 750 mg/dL or a cholesterol level meeting NCEP guidelines for use of a lipid lowering agent.

The aforementioned viral load and CD4 cell count restrictions do not apply to this latter group of patients. Entry criteria are based on the experience BMS has to date with atazanavir and are designed to ensure an appropriate benefit/risk ratio.

Some restrictions will apply during the initial phase of the EAP, regarding combined use of atazanavir with some of the other medications available for the treatment of HIV, until more is known about drug interactions between these agents and atazanavir.

It should be emphasised that little is known about the potency of atazanavir in highly pretreated patients.