Biotest AG said Tuesday that the United States Food and Drug Administration raised no questions on the clinical efficacy and safety of the newly developed investigational polyspecific immunoglobulin preparation, Bivigam, by the company's subsidiary Biotest Pharmaceuticals Corp.
However, the FDA did not grant the preparation's approval in the US because the agency has requested a new and additional validated test system for detection of thrombogenic activity, Biotest said.
Such a test system has not historically incorporated in the routine batch release process of immunoglobulins, but is now required by the FDA for the approval of Biotest's newly developed preparation, the company said.
An elevated content of thrombogenic factors led to the temporary withdrawal of a competitor's product in Europe and the US. As a result, new test methods have been developed over the past months but still require validation.
Biotest said it is currently working in a co-operation with a reference laboratory on the validation of such a test.
The company said the development will likely take several months. Biotest then expects the FDA marketing approval in the US.
Despite the delay, Biotest confirmed its given guidance for sales and profit in 2012.
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