Albireo's Rare Liver Disease Drug Bylvay Scores Back To Back Approvals In Europe, US

  • Just a day after European approvalAlbireo Pharma Inc ALBO has received FDA approval for Bylvay (odevixibat), the first drug approved to treat pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC).
  • PFIC afflicts children with severe, progressive liver disease.
  • The FDA approved Bylvay based on phase 3 trials showing that the drug can help ease pruritus and reduce serum bile acids. It isn't yet known whether it can reduce the need for liver transplants.
  • The approval marks a high point for the company, spun out of AstraZeneca PLC AZN way back in 2008.
  • Since then, it went public through a reverse merger and was later forced to shed its nonalcoholic steatohepatitis (NASH) candidate. It failed to achieve proof-of-concept for key NASH measures.
  • FDA issued a Rare Pediatric Disease Priority Review Voucher (PRV), which the company plans to monetize.
  • It had cash and cash equivalents of $186.3 million as of June 30 and anticipates the 2021 operating cash burn of $130 million to $135 million.
  • Excluding any proceeds from the planned sale of the PRV, the company believes that its cash balance will fund its expenses into 2023.
  • Albireo is kicking off an "immediate" launch.
  • Price Action: ALBO shares are up 3.41% at $35.50 during the premarket session on the last check Wednesday.
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Posted In: BiotechNewsHealth CareSmall CapFDAGeneralBriefsLiver DiseasePediatrics
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