Infant Bacterial Therapeutics AB (publ) (“IBT”) announces that the U.S. Food and Drug Administration (FDA) has awarded IBT Rare Pediatric Disease Designation for its drug candidate IBP-9414, intended for the prevention necrotizing enterocolitis in premature infants.
Rare Pediatric Disease Designation is intended to encourage development of new drug and biological products for the prevention and treatment of certain rare pediatric diseases. Having obtained the Rare Pediatric Disease Designation, FDA may award IBT a priority review voucher. A priority review voucher means that FDA ought to handle a drug application faster than normal.
Staffan Strömberg, Chief Executive Officer of IBT, commented, “The fact that FDA has given IBP-9414 Rare Pediatric Disease Designation, confirms how important it is to reach our goal that fewer premature babies shall be affected by the deadly disease necrotizing entercolitis, whilst at the same time this can reduce the time for this product to reach the market.”
For additional information please contact
Staffan Strömberg, CEO, phone: +46 8 410 145 55
Peter Rothschild, Chairman of the Board, phone: +46 8 410 145 55
Infant Bacterial Therapeutics AB
111 21 Stockholm
Phone: +46 8 410 145 55
See Press Release in both Swedish and English: