The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. 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. Albireo has deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. 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. - Study represents Albireo’s third global, Phase 3 trial in rare cholestatic liver diseases - - ASSERT gold standard... | December 17, 2020 BOLD, the largest prospective intervention trial ever conducted in biliary atresia, is a double-blind, randomized, placebo-controlled trial which will enroll approximately 200 patients at up to 75 sites globally to evaluate the efficacy and safety of odevixibat in children with biliary atresia who have undergone a Kasai procedure before age three months. Albireo Pharma Overview: Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver or gastrointestinal diseases and disorders. In people with cholestatic liver diseases, the bile flow is interrupted, resulting in elevated levels of toxic bile acids accumulating in the liver and serum. 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. The Company completed IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. The Company has also initiated the ASSERT double-blind, randomized, placebo-controlled global Phase 3 trial of odevixibat in Alagille syndrome to evaluate the safety and efficacy of odevixibat in relieving pruritus in patients with Alagille syndrome. The double-blind, randomized, placebo-controlled trial is designed to evaluate the safety and efficacy of 120 µg/kg/day odevixibat for 24 weeks in relieving pruritus in patients with ALGS. Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Albireo recently submitted for a New Drug Application (NDA) to the U.S. FDA and a Marketing Authorization Application (MAA) to the EMA seeking approval of odevixibat for the treatment of patients with PFIC. ASSERT is a gold standard, prospective intervention trial. About PFICProgressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. Price : $50 * Buy Profile. Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. The resulting bile build-up in liver cells causes liver disease and symptoms. Final gross price and currency may vary according to local VAT and billing address. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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. 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. 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. Albireo's odevixibat is a potent and selective IBAT inhibitor We are developing odevixibat initially to treat patients with PFIC, a rare genetic liver disease. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. 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). EMA has also granted orphan designation to odevixibat for the treatment of biliary atresia, Alagille syndrome and primary biliary cholangitis. Contact |  Terms of Use  |  Privacy Policy. The Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with PFIC and anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021. Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. Additional information on PFIC is available at https://www.pficvoices.com. BOSTON, Jan. 29, 2020(GLOBE NEWSWIRE) -- Albireo Pharma, Inc.(Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced a number of advances and new initiatives in the clinical program for odevixibat, an oral once-daily capsule in development for the treatment of progressive familial intrahepatic cholestasis (PFIC), biliary atresia … There are no drugs currently approved for PFIC, only surgical options that include partial external biliary diversion (PEBD) and liver transplantation. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. Odevixibat is also currently being evaluated in the BOLD (NCT04336722) Phase 3 clinical trial in patients with biliary atresia. Adis is an information provider. Odevixibat is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). Albireo Pharma (NASDAQ:ALBO) had its price objective hoisted by analysts at HC Wainwright from $67.00 to $75.00 in a research report issued on Friday, AR Network reports. The Company provides an Expanded Access Program for eligible patients with PFIC in the U.S., Canada, Australia and Europe. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. Currently, there is no approved drug therapy for the treatment of ALGS. 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 disclaims any obligation to update any forward-looking statement, except as required by applicable law. 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. BOSTON, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile … The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. Albireo Pharma (NASDAQ: ALBO) announces new data in progressive familial intrahepatic cholestasis (PFIC) confirming statistically significant reductions … We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs. 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. 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. 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. Albireo cautions you not to place undue reliance on any forward-looking statement. Albireo is developing odevixibat to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis, biliary atresia and Alagille syndrome. There are several forms of PFIC, but Albireo Pharma's phase 3 study focused on PFIC1 and PFIC2. On December 8, 2020, Albireo Pharma, Inc. issued a press release announcing that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). The Boston Business Journal named Albireo … Albireo Pharma is located in Boston, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. Cells causes liver disease Track, rare Pediatric cholestatic liver diseases, including familial! 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