Acute renal drug BB3 has been granted fast-track status and designated as an orphan drug product by the US Food and Drug Administration (FDA).
Angion Biomedica is currently researching BB3 in Phase II clinical trials, and hopes the drug can help improve organ function through protective, reparative and regenerative mechanisms.
BB3 is an activator of the pathway induced by interaction of hepatocyte growth factor and its receptor, a kinase that triggers a powerful reparative response.
The FDA’s fast-track designation allows for expedited regulatory review of drugs that have the potential to treat an unmet medical need.
The orphan drug designation offers assistance in regulatory development and economic incentives once a drug is approved.