Albireo ALBO announced that the FDA has approved Bylvay (odevixibat) to treat intense itching or pruritus in progressive familial intrahepatic cholestasis (“PFIC”).
PFIC, a rare disorder, is a type of cholestasis or impaired bile flow caused by genetic mutations. This results in bile build-up in liver cells that causes progressive, life-threatening liver diseases including cirrhosis and liver failure. Pruritis is the most prominent and problematic ongoing PFIC symptom.
The FDA approval makes Bylvay — a potent, non-systemic ileal bile acid transport inhibitor — the first and only drug to treat pruritus in all subtypes of PFIC.
The company is anticipating an immediate launch of Bylvay for commercialization. The company is also partnering with Travere Therapeutics TVTX for sales promotion of the product in the United States.
Shares of Albireo have declined 8.5% so far this year in comparison with the industry’s 2.3% decrease.
Image Source: Zacks Investment Research
Bylvay was approved in Europe earlier this week. The commercial launch of the drug in Europe is expected in September, starting with Germany, having the largest EU market potential.
The FDA and EU approvals were based on positive data from phase III PEDFIC 1 and PEDFIC 2 studies that evaluated patients with PFIC. Both the studies achieved sustained serum bile acid reduction and improvement in pruritus assessment, with no serious treatment-related adverse events.
PFIC mainly affects young children. Until now, there were only surgical options for those suffering from PFIC, without which patients could not survive past 30 years of age. Albeiro provides a non-invasive therapy option as Bylvay can be administered either as a capsule or sprinkled onto soft foods. Bylvay has the potential of changing the course of treatment for PFIC and is expected to drive the company’s prospects.
We inform investors that the FDA has issued a Rare Pediatric Disease Priority Review Voucher to Alberio, which it plans to monetize in order to fund its operating expenses and capital expenditure requirements beyond 2023.
Albireo is also developing Bylvay in other rare pediatric cholestatic diseases. A phase III study — BOLD — is evaluating the drug in biliary atresia. Another late-stage study, ASSERT, is evaluating the drug in patients with Alagille syndrome. Top-line data from the BOLD and ASSERT studies is anticipated in 2024 and 2022, respectively.
Zacks Rank & Stocks to Consider
Albireo currently carriesa Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector include Biomarin Pharmaceutical BMRN and Exact Sciences EXAS, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Biomarin’s earnings estimates for 2022 have increased from $2.33 to $2.35 per share in the past 60 days.
Exact Sciences’ loss estimates for 2021 have narrowed from $2.65 to $2.51 per share in the past 60 days.
ALBIREO PHARMA Price
ALBIREO PHARMA price | ALBIREO PHARMA Quote
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report
Exact Sciences Corporation (EXAS) : Free Stock Analysis Report
ALBIREO PHARMA (ALBO) : Free Stock Analysis Report
Travere Therapeutics, Inc. (TVTX) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research