Exciting News from 89bio, Inc.! U.S. FDA has Granted Breakthrough Therapy Designation for Pegozafermin in NASH
The U.S. FDA has granted Breakthrough Therapy Designation (BTD) for 89bio, Inc.'s pegozafermin, a new drug candidate for non-alcoholic steatohepatitis (NASH).
The BTD is designed to expedite the development and review for new drug candidates and recognized by the U.S. FDA as promising for the treatment of serious or fatal diseases for which no therapeutic yet exists.
Now that pegozafermin has been granted BTD based on the results of the ENLIVEN Phase 2b trial for NASH, it may be possible to conduct future Phase 3 trials and accelerate the speed of development until it is launched as a NASH drug.
Currently, pegozafermin has also shown anti-cancer effect against NASH-HCC in STAM™ mice, suggesting that this compound may be a comprehensive, innovative drug for liver disease associated with NASH.
Further development of 89bio's pegozafermin is expected in the future!
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■89bio‘s press release
89bio Announces U.S. FDA has Granted Breakthrough Therapy Designation for Pegozafermin in Nonalcoholic Steatohepatitis (NASH)
■For more information on anti-cancer effect of pegozafermin on NASH-HCC in STAM™ mice, click here.