albireo pharma odevixibat

albireo pharma odevixibat

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As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. Liver damage is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. About OdevixibatOdevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome. But, for these patients, there may be a bright light at the end of the tunnel in the form of Albireo Pharma’s ileal bile acid transport inhibitor (IBATi) odevixibat. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being investigated for the treatment of rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome (ALGS). Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. Secondary endpoints will measure serum bile acid levels and safety and tolerability. Odevixibat does not require refrigeration and can be taken as a capsule for older children, or opened and sprinkled onto food, which are factors of key importance for adherence in a pediatric patient population. ASSERT is a gold standard, prospective intervention trial. The Company completed IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. Albireo Pharmaceuticals Boston, USA-based biotech Albireo Pharma has submitted a New Drug Application (NDA) to the US Food and… To continue reading The Pharma Letter please login , subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space. Albireo is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. Albireo is committed to the development of new medicines to improve the lives of patients suffering from liver diseases and their families. Odevixibat is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). Accordingly, a product capable of inhibiting the IBAT could lead to a reduction in bile acids returning to the liver and may represent a promising approach for treating cholestatic liver diseases. Albireo is developing odevixibat to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis, biliary atresia and Alagille syndrome. We do not sell or distribute actual drugs. Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. EMA has also granted orphan designation to odevixibat for the treatment of biliary atresia, Alagille syndrome and primary biliary cholangitis. Albireo Pharma (ALBO) Begins Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome . About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. The Company provides an Expanded Access Program for eligible patients with PFIC in the U.S., Canada, Australia and Europe. About PFICProgressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan paediatric liver diseases and other liver or gastrointestinal diseases and disorders. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of odevixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia (BOLD), and the  pivotal trial for odevixibat in Alagille syndrome (ASSERT); the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for odevixibat in PFIC, the pivotal trial for odevixibat in biliary atresia, the pivotal trial for odevixibat in Alagille syndrome; the potential approval and commercialization of odevixibat; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of odevixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of odevixibat of the treatment of PFIC patients and its potential to improve the current standard of care; the potential benefits of an orphan drug designation; the potential issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Patients have impaired bile flow, or cholestasis, caused by genetic mutations. There are no drugs currently approved for PFIC, only surgical options that include partial external biliary diversion (PEBD) and liver transplantation. Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first three months of life, and as many as 88% also present with severe, intractable pruritus. With limited treatment options beyond invasive medical procedures, cholestatic liver diseases are devastating for adults and children. Odevixibat - Albireo AB Alternative Names: A-4250 Latest Information Update: 10 Nov 2020. - Study represents Albireo’s third global, Phase 3 trial in rare cholestatic liver diseases -, - ASSERT gold standard study design in Alagille syndrome -, - Product submission of once-daily odevixibat for patients with PFIC under review by FDA and EMA -. Lucy Parsons Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Albireo Pharma (NASDAQ: ALBO) announces new data in progressive familial intrahepatic cholestasis (PFIC) confirming statistically significant reductions … Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. Odevixibat is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). The firm currently has a “buy” rating on the biopharmaceutical company’s stock. About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. ALGS is a rare multisystem genetic disorder that can affect the liver, heart and other parts of the body. Both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have agreed on the study design and have indicated that a single study demonstrating safety and efficacy of odevixibat would be sufficient for regulatory filings. About Albireo Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. The EMA has granted odevixibat accelerated assessment, orphan designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Damaged or absent bile ducts outside the liver result in bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis and even liver failure. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” and similar expressions to identify forward-looking statements. Approximately 95% of patients with ALGS present with chronic cholestasis, usually within the first three months of life, and up to 88% also present with severe, intractable pruritus. About AlbireoAlbireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. Its Paediatric Committee has agreed to Albireo's odevixibat Pediatric Investigation Plan for PFIC and biliary atresia. With U.S. and EU regulatory submissions for odevixibat in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021. Odevixibat is being evaluated in the ongoing PEDFIC 2 open-label trial (NCT03659916) designed to assess long-term safety and durability of response in a cohort of patients rolled over from PEDFIC 1 and a second cohort of PFIC patients who are not eligible for PEDFIC 1. BOSTON, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced the initiation of its global Phase 3 pivotal trial, ASSERT, Alagille Syndrome looking at Safety and Efficacy in a Randomized controlled Trial, which will evaluate odevixibat in patients with Alagille syndrome. Other symptoms include jaundice, poor weight gain and slowed growth. The randomized, double-blind, placebo-controlled, global multicenter PEDFIC 1 Phase 3 clinical trial of odevixibat in 62 patients, ages 6 months to 15.9 years, with PFIC type 1 or type 2 met its two primary endpoints demonstrating that odevixibat reduced serum bile acids (sBAs) (p=0.003) and improved pruritus (p=0.004). Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. HC Wainwright’s price target indicates a potential upside of 83.91% from the company’s previous close. Children have clay-colored or no color in their stools and jaundice, among other things, and a few patients are pruritic. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. Adis is an information provider. Additional information on PFIC is available at https://www.pficvoices.com. Albireo Pharma (NASDAQ:ALBO) has submitted a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA seeking approval of odevixibat … We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. Media Contact:Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.comLisa Rivero, 617-947-0899, lisa.rivero@syneoshealth.com, Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177, Contact |  Terms of Use  |  Privacy Policy, Albireo Initiates Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis (PFIC). About Alagille SyndromeAlagille syndrome (ALGS) is a rare, multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys and facial features. Albireo has deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of odevixibat to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of odevixibat; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration of the double-blind Phase 3 trial in patients with PFIC are sufficient to support approval of odevixibat in the United States or the European Union, to treat PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of odevixibat, including the pivotal program in biliary atresia or the pivotal program in Alagille syndrome, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in the recruitment of patients for, or the conduct of, company’s clinical  trials; and Albireo’s critical accounting policies. - Albireo AB Alternative Names: A-4250 Latest information Update: 10 2020... 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