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Inhibitex
gets Orphan Drug status for Staph. drug
Atlanta
INHIBITEX Inc has received orphan designation from the United States
Food and Drug Administration (FDA) for the use of a human immunoglobulin
to prevent hospital-acquired staphylococcal infections in very low
birth weight infants, a company release stated.
In addition to other related benefits, orphan designation of its
product entitles Inhibitex to exclusive marketing rights in the
United States for seven years following market approval and a waiver
from the FDA’s application user fee. In the past, orphan drug
designation has been associated with other biopharmaceuticals such
as Avonex, Epogen, Neupogen and Synagis.
‘‘Our
human immunoglobulin product, which is aimed at preventing both
Staphylococcus aureus (S. aureus) and Coagulase Negative Staphylococci
(S. epidermidis) infections in very low birth weight infants, is
quickly advancing toward the clinic,’’ stated Juan Walterspiel,
MD, FAAP, vice- president of Clinical and Regulatory Affairs.
‘‘There
are approximately 57,000 such infants born in the US annually, of
which approximately 20% will develop a staphylococcal infection.
Currently, there are no proven methods to prevent staphylococcal
infections, many of which are caused by organisms that are highly
resistant to antibiotics. For these fragile neonates, these infections
typically result in a significant increase in the length of their
hospital stay, extended use of ventilators, restrictions in oral
feedings and increased antibiotic use,’’ he added.
PRNewswire
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