In documents posted to the FDA’s website on Monday, agency staff suggested that Theravance’s experimental antibiotic telavancin should receive a boxed warning specifying that the drug should not be given to pregnant women. In addition, FDA reviewers raised concerns about an “imbalance” in the number of renal adverse events observed among patients who were treated with telavancin, compared with those who received vancomycin. An advisory panel is scheduled to discuss the matter on Wednesday.

The drugmaker is seeking approval for the compound to treat complicated skin and skin structure infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). FDA reviewers noted that based on two clinical trials, the antibiotic was about as effective as vancomycin, but that the benefit appeared to decline in patients with kidney problems. Theravance noted that “the safety profile of telavancin in these studies was compatible with treatment of patients with serious infections.”

The US regulator also indicated that it would ask the advisory panel to consider whether a risk-management programme would be needed to prevent pregnant women from receiving the drug, because data from animal studies suggest that it may be detrimental to foetuses.

Commenting on the news, Cowen and Co. analyst Rachel McMinn stated that the review contains ”nothing shocking” and that telavancin will likely “get a mixed approval recommendation from the committee, but will have restrictions in renally impaired patients and receive a [boxed] warning in pregnancy.” May-Kin Ho of Goldman Sachs has suggested that ”the efficacy of telavancin should support approval and the side effects are manageable. Therefore, we remain cautiously optimistic about FDA approval in 2009.”

If approved, the drug would be marketed by Astellas.

Source: FirstWord

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