Inhibitex Inc. has received several regulatory approvals related to its lead drug candidate, Veronate for the prevention of hospital- associated infections in very low birth weight infants.
The European Medicines Agency (EMEA) has issued the company a favourable opinion to grant orphan medicinal product (OMP) designation for Veronate in Europe for the prevention of late onset sepsis in premature infants of less than 32 weeks gestational age, states a company release.
Dr. David Wonnacott, vice president of regulatory affairs and quality at Inhibitex stated, "Receiving OMP designation is the first tangible step in our development strategy for Veronate outside of North America. Pending the outcome of our Phase III study, we intend to seek scientific advice from the EMEA regarding a marketing application for Veronate in Europe."
Inhibitex expects to receive formal approval of the OMP designation from the European Commission within the next several months.
The United States Food and Drug Administration has indicated Inhinitex that in addition to the pre-determined primary endpoint of the 2,000 patient pivotal Phase III trial, the FDA will consider the licensure of Veronate based upon a sub-group analysis of data from that trial. Specifically, the FDA has now proposed that if the primary endpoint of preventing Staphylococcus aureus (S. aureus) bloodstream infections (late onset sepsis) in premature, very low birth weight infants weighing between 500 and 1,250 grams at birth is not achieved in the overall study population, but is achieved in a lower birth weight group, licensure could be granted for that lower birth weight population.
"We are very pleased with these regulatory developments. We believe that the FDA's flexibility in considering the licensure of Veronate on a sub-group basis reflects the severity of the unmet medical need in the most vulnerable neonates. It is well documented that premature, very low birth infants have a much higher probability of infection as their birth weight decreases, and we believe that Veronate may have the greatest potential impact in these smaller neonates," stated Wonnacott.
In a Phase II trial of Veronate in premature infants weighing between 500 and 1,250 grams at birth, a higher infection rate was observed in the lower birth weight infants.
The company recently completed enrolment in its 2,000 patient pivotal Phase III trial of Veronate and anticipates that top line data from this trial will be available in the second quarter of 2006. The FDA has granted Veronate both fast track designation and orphan drug status. The company has retained all world-wide rights to Veronate and, if approved, anticipates commercialising it independently in the United States.
Inhibitex Inc. is a biopharmaceutical company that discovers, develops and commercialises antibody-based products for the prevention and treatment of serious, life-threatening infections.