Pharma Focus Europe

Infant Bacterial Therapeutics' New Product Receives FDA Orphan Drug Designation

Tuesday, July 04, 2023

IBT has received orphan drug designation from the FDA for their product IBP-1016, which is intended for the treatment of gastroschisis. Gastroschisis is a rare condition in infants that poses risks such as growth retardation, sepsis, and NEC, often resulting in increased mortality rates. Hospital stays for infants with this condition are typically lengthy and expensive.

Orphan drugs are medications or biologics developed to diagnose, prevent, or treat rare diseases or disorders affecting fewer than 200,000 patients in the USA annually. By granting orphan drug designation, the FDA provides certain benefits to the applying company, such as tax reductions and exclusive market rights, in exchange for their commitment to developing the drug.

It's important to note that the approval of orphan drug designation does not exempt the company from standard regulatory requirements and processes for obtaining marketing approval. All aspects of the drug's development, including documentation of clinical safety and efficacy, must still be thoroughly investigated to obtain market authorization.

IBT's CEO, Staffan Strömberg, expressed the significance of this milestone, stating, "This is the first time the FDA has granted orphan drug designation for gastroschisis. This is important as there are no treatments available for this serious disease. We are now exploring the most suitable development pathway to obtain market authorization."

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