Benzinga | Jan 25, 2022 08:10AM EST

Catalyst Biosciences Receives Rare Pediatric Disease Designation For CB 4332 For The Treatment Of CFI Deficiency

Catalyst Biosciences, Inc. (NASDAQ:CBIO) today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for CB 4332 for the treatment of Complement Factor I (CFI) deficiency (CFID).

"The granting of the Rare Pediatric Disease Designation for CB 4332 underscores the significant unmet medical need in pediatric patients with CFID. We are focused on efficiently advancing the development of CB 4332 and our complement medicines portfolio in a number of complement-driven diseases in hematology, nephrology and ophthalmology. We are pleased with the FDA's assessment of CB 4332 as a potential therapy for underserved pediatric patients with CFID and the granting of the RPDD," said Nassim Usman, Ph.D., chief executive officer of Catalyst Biosciences.

Under the FDA's rare pediatric disease designation program, the FDA may grant a priority review voucher to a sponsor who receives a product approval for a rare pediatric disease. A rare pediatric disease is defined as a serious or life-threatening condition that affects less than 200,000 individuals in the U.S. per year and who are primarily less than 18 years of age.