FDA may approve Inhibitex therapy on sub-group analysis

Inhibitex said that the FDA has may approve its experimental therapy Veronate to prevent infections in low-weight, newborn babies even if it fails to hit its primary endpoint in an ongoing Phase III trial. According to Inhibitex, the agency will consider approving the therapy based on a sub-group analysis of data for very low-weight infants. The Atlanta-based drug developer added that the European Medicines Agency has issued a favorable opinion to grant Orphan Medicinal Product designation for Veronate in Europe.

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