Inhibitex: FDA may OK Veronate for sub-group of low birth weight babies, European regulators grant orphan status

By E. Janene Geiss

Philadelphia, Nov. 29 - Inhibitex, Inc. announced Tuesday several positive regulatory developments related to its lead drug candidate, Veronate for the prevention of hospital-associated infections in very low birth weight infants.

The U.S. Food and Drug Administration has indicated that in addition to the pre-determined primary endpoint of the 2,000 patient pivotal phase 3 trial, the FDA will consider the licensure of Veronate based upon a sub-group analysis of data from that trial, according to a company news release.

Inhibitex said the FDA now has proposed that if the primary endpoint of preventing Staphylococcus 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, a license could be granted for that lower birth weight population.

The company also said the European Medicines Agency has issued a favorable opinion to grant Orphan Medicinal Product designation for Veronate in Europe for the prevention of late onset sepsis in premature infants of less than 32 weeks gestational age.

"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," said David Wonnacott, Inhibitex vice president of regulatory affairs and quality, in the release.

Inhibitex said it expects to receive formal approval of the orphan designation from the European commission within the next several months. The designation is granted to drugs that are being developed to prevent or treat life-threatening or very serious conditions that impact not more than five out of 10,000 individuals in the European Union.

The designation also provides for 10 years of market exclusivity versus similar drugs for the same indication, officials said.

Other benefits include a reduction in fees associated with marketing applications and access to scientific advice from the European commission at no cost, officials said.

The company recently completed enrollment in its 2,000 patient pivotal phase 3 trial and anticipates that top line data will be available in the second quarter of 2006.

The FDA has granted Veronate both Fast Track designation and Orphan Drug status. The company said it has retained all worldwide rights to Veronate and, if approved, anticipates commercializing it independently in the United States.

Inhibitex is an Alpharetta, Ga., biopharmaceutical company focused on development and commercialization of antibody-based products for the prevention and treatment of serious, life-threatening infections.

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