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Published on 18 November 2008

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Drug approval sought despite danger

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An experimental antibiotic is expected to be approved by the US drugs watchdog despite concerns about the product’s risks to pregnant women.

Drugmaker Theravance has asked the Food and Drug Administration (FDA) to approve telavancin for hard-to-treat skin infections caused by Gram-positive bacteria. Gram-positive bacteria are highly resistant to many antibiotics on the market.

An FDA review of the product contained “nothing shocking”, despite highlighting potential safety issues for kidney failure patients and pregnant women, Cowen Co analyst Rachel McMinn said.

The FDA delayed a decision on the injectable treatment last October, asking Theravance to work on manufacturing issues and submit new clinical data.

The agency will now ask a panel of antibiotic experts to assess the safety and effectiveness of the once-a-day treatment.

Regulators plan to ask the panel whether telavancin’s risks to pregnant women outweigh its benefits.

Ms McMinn believes the antibiotic is likely to win approval, but with restrictions for certain patient groups.

“We believe telavancin will get a mixed-approval recommendation from the committee, but will have restrictions in renally impaired patients and receive a black-box warning in pregnancy,” she said.

Copyright Press Association 2008

FDA



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