An FDA advisory committee voted unanimously in favour of agency draft guidelines for developing generic versions of ViroPharma’s antibiotic Vancocin (vancomycin) that do not require comparative studies in humans to establish bioequivalence, the company reported on Wednesday.
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The proposed guidelines allow the use of in vitro testing to establish bioequivalence for generic versions of the product, which is approved to treat severe infections of the gastrointestinal tract, Clostridium difficile infection (CDI) and enterocolitis caused by Staphylococcus aureus. Committee member Thomas Moore remarked that given the increase in cases of serious Clostridium difficile infection, “it seems more important than ever to increase access to oral vancomycin.”
The drugmaker argued that “the proposed in vitro test conditions do not mimic the in vivo environment of the CDI patient and the qualitative and quantitative sameness…is inadequate given formulation and critical manufacturing process controls, and lacks correlation with clinical effects.” ViroPharma CEO Vincent Milano said he believes the favourable vote “puts patients seriously at risk.” The FDA is scheduled to render its final decision on whether to adopt the draft guidelines later this year.
Commenting on the news, Deutsche Bank analyst Robyn Karnauskas said investors had anticipated the panel decision and are looking at potential future growth to be driven by the company’s hereditary angioedema drug, Cinryze. Vancocin generated sales of $232 million in 2008.
Source: FirstWord
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