Apache iBATIS

U.S. FDA approves Bylvay® for patients living with cholestatic pruritus due to Alagille syndrome

Retrieved on: 
Tuesday, June 13, 2023

Bylvay was approved as the first drug treatment option for patients living with cholestatic pruritus due to progressive familial intrahepatic cholestasis (PFIC) in the U.S., and for the treatment of PFIC in Europe, in 2021.

Key Points: 
  • Bylvay was approved as the first drug treatment option for patients living with cholestatic pruritus due to progressive familial intrahepatic cholestasis (PFIC) in the U.S., and for the treatment of PFIC in Europe, in 2021.
  • More than 90% of patients were pruritus responders (≥ 1 point change at any time during 24 weeks).
  • No patients discontinued the study and 96% of patients rolled over into the open-label extension study.
  • In a third indication, the rare pediatric cholestatic liver disease, biliary atresia, Bylvay is in late-stage development with the Phase III BOLD trial.

Ipsen completes acquisition of Albireo, expanding the scope of its Rare Disease portfolio

Retrieved on: 
Thursday, March 2, 2023

The acquisition enriches Ipsen’s Rare Disease portfolio, with promising therapeutics for pediatric and adult rare cholestatic-liver diseases, innovative pipeline potential, as well as scientific and commercial capabilities.

Key Points: 
  • The acquisition enriches Ipsen’s Rare Disease portfolio, with promising therapeutics for pediatric and adult rare cholestatic-liver diseases, innovative pipeline potential, as well as scientific and commercial capabilities.
  • “The acquisition of Albireo will greatly strengthen our portfolio in rare diseases,” said David Loew, Chief Executive Officer of Ipsen.
  • “I am excited to welcome new colleagues to Ipsen, who led the innovation on the development of novel bile acid modulators, like Bylvay, to treat rare liver diseases in children and adults.
  • As part of the transaction, Ipsen has also acquired A3907 and A2342, two clinical-stage assets in Albireo’s pipeline.

FDA Grants June 15, 2023 PDUFA Date to Albireo for Bylvay® in Alagille Syndrome

Retrieved on: 
Tuesday, February 14, 2023

With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in mid-2023.

Key Points: 
  • With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in mid-2023.
  • Over 90% of patients were pruritus responders and Bylvay was generally well tolerated; the overall incidence of treatment emergent adverse events (TEAEs) was similar to placebo.
  • “As an advocate for Alagille families, it is great to know physicians may have another drug treatment option for the debilitating pruritus that affects so many Alagille patients,” said Roberta Smith, President, Alagille Syndrome Alliance.
  • Alagille syndrome, or ALGS, is a rare, multisystem genetic disorder that the Company estimates impacts 25,000 people globally.

Ipsen to Acquire Albireo Accelerating Growth in Rare Disease With Treatments for Several Pediatric Liver Diseases

Retrieved on: 
Monday, January 9, 2023

Ipsen (Euronext: IPN: ADR: IPSEY) and Albireo (Nasdaq: ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases.

Key Points: 
  • Ipsen (Euronext: IPN: ADR: IPSEY) and Albireo (Nasdaq: ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases.
  • “Our Rare Disease franchise is strengthened with Bylvay, which, in addition to being the first-approved treatment in PFIC, has two further indications being investigated in rare liver conditions that are underserved.
  • “Our talented team at Albireo have advanced the first Phase III studies in three different pediatric liver diseases while discovering two promising new clinical stage bile acid modulators.
  • Goldman Sachs is acting as exclusive financial advisor to Ipsen and Orrick Herrington & Sutcliffe LLP as legal counsel to Ipsen.

Albireo Submits Bylvay® Alagille Syndrome Regulatory Filings to FDA and EMA

Retrieved on: 
Monday, December 19, 2022

BOSTON, Dec. 19, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a variation application to the European Medicines Agency (EMA) seeking approval for a second Bylvay indication for use in patients with Alagille syndrome (ALGS) in the second half of 2023.

Key Points: 
  • “The clear results from our ASSERT Phase 3 data allowed the Company to swiftly submit FDA and EMA regulatory filings,” said Ron Cooper, President and Chief Executive Officer of Albireo.
  • Over 90% of patients were pruritus responders and Bylvay was generally well tolerated; the overall incidence of treatment emergent adverse events (TEAEs) was similar to placebo​.
  • No patients discontinued the study​ and 96% of patients rolled over into the open-label extension study.
  • Alagille syndrome, or ALGS, is a rare, multisystem genetic disorder that the Company estimates impacts 25,000 people globally.

Albireo Announces Presentation of New Data in Pediatric and Adult Liver Diseases

Retrieved on: 
Thursday, June 23, 2022

Albireo also launched SPARK, a new grant-based program established to identify and drive improvements in the quality of care for rare liver diseases, beginning with PFIC in 2022.

Key Points: 
  • Albireo also launched SPARK, a new grant-based program established to identify and drive improvements in the quality of care for rare liver diseases, beginning with PFIC in 2022.
  • Key findings from the data include:
    Bylvay Responders Experience Improvements in Quality of Life Measures (poster #763).
  • Of 84 total patients in the pooled population, PedsQL data were available for 53 patients, and PEDsQL Family Impact (FI) data were available for 79 patients.
  • Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases.

CBC-backed Jadeite Medicines Announces Exclusive Licensing Agreement with Albireo Pharma to Develop and Promote Odevixibat in Japan

Retrieved on: 
Tuesday, October 12, 2021

Jadeite will be responsible for clinical development, regulatory approval and commercialization of odevixibat in Japan, where there is significant market opportunity.

Key Points: 
  • Jadeite will be responsible for clinical development, regulatory approval and commercialization of odevixibat in Japan, where there is significant market opportunity.
  • "This agreement reinforces Jadeite's commitment and vision to develop highly differentiated and innovative medicines to improve the health and quality of life of patients in Japan."
  • "The agreement allows for success of both companies, and we look forward to further collaboration with Jadeite."
  • "CBC remains steadfast in our commitment to widening access to medical care globally, and Jadeite is our cornerstone in Japan.

Albireo Announces Bylvay® (odevixibat) Now Available in Germany

Retrieved on: 
Wednesday, September 15, 2021

BOSTON, Sept. 15, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare pediatric liver disease company developing novel bile acid modulators, today announced that Bylvay (odevixibat), the first drug approved in Europe for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC), is now available by prescription to patients in Germany. Bylvay is also approved in the U.S. for the treatment of pruritus in all types of PFIC. A potent, non-systemic ileal bile acid transport inhibitor (IBATi), Bylvay is administered as a once-daily capsule or opened and sprinkled onto soft foods and does not require refrigeration.

Key Points: 
  • Bylvay is also approved in the U.S. for the treatment of pruritus in all types of PFIC.
  • Sales promotion has already begun, with Albireo commercial staff covering the key centers to inform them of the availability of Bylvay for the treatment of PFIC and the patient support services available.
  • We are excited to bring the first drug treatment option to PFIC patients in Germany, which has the largest market potential in Europe, said Pamela Stephenson, Chief Commercial Officer of Albireo.
  • Albireo has launched Bylvay in the U.S. and is working to commercialize Bylvay in other European countries.