Odevixibat is under clinical development by Ipsen and currently in Phase III for Biliary Atresia. According to GlobalData, Phase III drugs for Biliary Atresia does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Odevixibat LoA Report. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Odevixibat overview
Odevixibat Sesquihydrate (Bylvay) is acts by targeting ileal bile acid transporter (IBAT) which is developed based on specialized delivery technology in which the bile acids are neutralized in the large bowel. It is formulated as capsules, pellets, hard capsules for oral route of administration. Bylvay is indicated for the treatment of all subtypes of progressive familial intrahepatic cholestasis (PFIC).
A-4250 is under development for the treatment of pediatric cholestatic liver diseases such as primary sclerosing cholangitis, progressive familial intrahepatic cholestasis (PFIC), cholestatic pruritus, biliary atresia and alagille syndrome. It is administered as a once a daily capsule through oral route. The drug candidate acts by targeting ileal bile acid transporter (IBAT). The drug candidate is developed based on specialized delivery technology in which the bile acids are neutralized in the large bowel.
The drug candidate was under development for the treatment of pediatric cancer, primary biliary cholangitis (PBC), primary sclerosing cholangitis, nonalcoholic steatohepatitis (NASH) primary biliary cirrhosis, nonalcoholic fatty liver disease (NAFLD) and dyslipidemia.
Ipsen overview
Ipsen is a global specialty biopharmaceutical company engaged in the manufacturing and distribution of drugs for the treatment of cancer, rare diseases, and neurological diseases, including specialty pharmaceutical products. The company develops and commercializes novel medicines for cancer, neuroscience and rare diseases and offers products to treat gastrointestinal disorders, and neurodegenerative pathologies. Ipsen sells its drugs through a network of distributors and directly to hospitals in a few countries. The company operates its research and development facilities in Paris-Saclay, France; Oxford, the UK; and Cambridge, the US. The company offers products in Europe, North America, and rest of the world. Ipsen is headquartered in Paris, France.
For a complete picture of Odevixibat’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
