Benzinga | Jul 21, 2021 06:10AM EDT

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

* Just a day after European approval, Albireo Pharma Inc (NASDAQ: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 (NASDAQ: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.