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BMS hepatitis drug set for approval

Published on 17/03/05 at 10:12am

Bristol-Myers Squibb's Baraclude (entecavir) has been recommended for first-line treatment of chronic hepatitis B despite potential cancer risks.

The US Food and Drugs Administration (FDA) Antiviral Drugs Advisory Committee issued a unanimous approval for the oral antiviral agent after studying both pre-clinical and clinical data.  

BMS also discussed plans for a long-term efficacy and safety programme with the committee which will forward its recommendations to its senior regulatory arm, the FDA, which is expected to back the approval.

The committee agreed Baraclude showed superior efficacy and similar safety to GlaxoSmithKline's Epivir (lamivudine), the most commonly prescribed oral antiviral therapy in the US, and ruled that this outweighed the cancer risks associated with the treatment.

The committee said rodent carcinogenicity studies which showed tumour growth at maximum tolerated levels should not impact the product's indication, emphasising that the risk was not significant enough to warrant a black box warning.

Committee member John Gerber said: "This should be a first-line treatment. We try to use the most effective therapy if that doesn't result in resistance and this seems to be the case right now for entecavir."

BMS filed the drug in the US in September of last year and it was granted a priority review, which is reserved for treatments which address unmet medical needs.

The company has now proposed a post-marketing randomised study in 12,500 patients to detect longer term cancer risk in patients taking Baraclude.


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