FDA Grants Infant Bacterial Therapeutics Orphan Drug Status

The FDA has granted an Orphan Drug designation to Sweden-based Infant Bacterial Therapeutics’ investigational drug arginyl-glutamine dipeptide to prevent retinopathy of prematurity (ROP), a condition that can lead to blindness among prematurely born babies.

The eye disorder, which is caused by abnormal blood vessel growth in the retina of premature infants, typically affects infants born before week 31 of pregnancy and weighing 2.75 pounds or less at birth.

The drug candidate is being evaluated to see whether it can be given at a stage that will prevent early onset of the disease and either decrease or eliminate the need for future invasive procedures.

The FDA grants orphan status to certain drugs or biologics for treatment, diagnosis or prevention of rare diseases or disorders. Orphan drugs are intended to treat a condition affecting fewer than 200,000 individuals in the United States.