Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC.
Pankaj R. Patel, Chairman, Zydus Group said, “We are pleased that the EMA has granted an Orphan Drug Designation to Saroglitazar Mg for the treatment of Primary Biliary Cholangitis (PBC). This is a serious health condition and we are committed in our clinical development efforts to improve the quality of life of patients suffering from PBC with safe and efficacious treatment.”
As per the regulatory filing, Orphan drug status in Europe is given to medicines with the potential to be safe and effective treatments for rare, life-threatening, or chronically debilitating conditions affecting no more then 5 people in 10,000 people. It provides companies with a range of incentives, including assistance with trial protocols, reduced regulatory fees, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU Member States, and 10 years of market exclusivity if the treatment eventually is approved.
Saroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist. Results of PHASE 2, prospective multicentre randomized double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of Saroglitazar
Mg in patients with PRIMARY BILIARY CHOLANGITIS (EPICS) was presented earlier at the Liver Meeting® in 2020, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) [ClinicalTrials.gov Identifier: NCT03112681].
The treatment options are still evolving for PBC and Saroglitazar holds immense potential based on its safety and efficacy profile so far. The global market for PBC treatment is expected to grow at a CAGR of 36.3% from 2018 – 2026 and is expected to reach USD 10.8 bn by 2026 as per Coherent market insights.
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