Primary Biliary Cholangitis (PBC) is a rare disease characterized by chronic progressive liver disorder. It majorly affects women and usually occurs in middle age ranging between 30 to 60 years. It is also called as biliary cirrhosis. PBC tends to affect the small bile duct present in the liver. Primary biliary cholangitis is divided into four stages including stage 1 with no significant scarring to stage 4 known as cirrhosis. PBC is triggered by the combination of factors such as autoimmune, genetic, and environmental factors.
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Increasing number of Food and Drug Administration (FDA) approvals for the drugs to treat PBC is contributing to the market growth. For instance, in May 2016, the U.S. Food and Drug Administration (FDA) approved Ocaliva (obeticholic acid) in combination with ursodeoxycholic acid (UDCA) for the treatment of Primary Biliary Cholangitis (PBC) in adults with an inadequate response to UDCA. Furthermore, in 2016, Ocaliva was assigned fast track designation and orphan drug designation by the U.S. FDA.
Moreover, in February 2018, U.S.FDA granted orphan drug designation (ODD) to Calliditas Therapeutics AB, specialty pharmaceutical company engaged in development of high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in Stockholm, Sweden, for the treatment of Primary biliary cholangitis (PBC).
Furthermore, key players are engaged in conducting clinical trial to develop treatment for primary biliary cholangitis. For instance, in February 2017, Zydus Cadila received the US Food and Drug Administration (USFDA) approval to initiate a Phase-2 clinical trial of Saroglitazar Magnesium (Mg) in patients with Primary Biliary Cholangitis of the liver.
Increasing number of pipeline studies is expected to drive the primary biliary cholangitis treatment market growth
Increasing pipeline studies to develop prominent treatments for rare diseases such as primary biliary cholangitis are expected to boost the primary biliary cholangitis treatment market size. For instance, in October 2018, CymaBay Therapeutics, Inc., initiated placebo-controlled and randomized phase 3 clinical trial for seladelpar 5-10mg. The aim of the study was to evaluate safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and to determine inadequate response or intolerance to ursodeoxycholic acid (UDCA). The study is estimated to complete in December 2021.
Moreover, in January 2017, GlaxoSmithKline (GSK) initiated phase 2 clinical trial to study the efficacy, safety, and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). GSK2330672 is a selective inhibitor of human ileal bile acid transporter (IBAT). The study is estimated to complete in April 2020.
Primary Biliary Cholangitis Treatment Market- Regional Analysis
Regional segmentation of the global primary biliary cholangitis treatment market comprises North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.
North America is anticipated to witness lucrative primary biliary cholangitis treatment market growth, owing to growing initiatives by market players to develop advance treatment options for PBC. For instance, in October 2016, TARGET PharmaSolutions, Inc., U.S.-based Company, in collaboration with Intercept Pharmaceuticals, Inc., launched its TARGET-PBC (Primary Biliary Cholangitis) platform. TARGET-PBC platform has been created to improve the understanding of real world treatment patterns in PBC.
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Primary Biliary Cholangitis Treatment Market – Competitive Landscape
Key players operating in the primary biliary cholangitis treatment market include Novartis AG, Bristol-Myers Squibb, NGM Biopharmaceuticals, Lumena Pharmaceuticals, Inc., TARGET PharmaSolutions, Inc., Intercept Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd, Retrophin, Inc., Calliditas Therapeutics AB., and GlaxoSmithKline (GSK) pharmaceutical.
This post was originally published on Trading Herald