Zydus granted fast track designation by the USFDA for Saroglitazar in the treatment of patients with PBC

▴ Zydus granted fast track designation by the USFDA for Saroglitazar in the treatment of patients with PBC
Fast Track is a process of the USFDA which expedites the review of drugs to treat serious conditions and fill an unmet medical need

Zydus, a leading discovery based, global pharmaceutical company today announced that United States Food and Drug Administration (USFDA) has granted “Fast Track Designation” to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC). Fast Track is a process of the USFDA which expedites the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation is eligible for Accelerated Approval and Priority Review, if the relevant criteria are met. The purpose is to get important new drugs to the patients faster. The global market for primary biliary cholangitis 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.

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, placebocontrolled study to evaluate the safety, tolerability and efficacy of Saroglitazar Mg in patients with PRIMARY BILIARY CHOLANGITIS (EPICS) was presented earlier at the The Liver Meeting 2020, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
The treatment options are still evolving for primary biliary cholangitis and Saroglitazar holds immense potential based on its safety and efficacy profile so far.

Speaking on the development, Pankaj R. Patel, Chairman, Zydus Cadila said, “The awarding of Fast Track Designation to Saroglitazar, an investigational candidate for the treatment of PBC, is an important recognition by USFDA to address the serious condition and bridge an unmet medical need in the treatment of PBC patients. We are very thankful to the USFDA for their timely and useful feedback on the clinical trial designs of Saroglitazar Mg and will continue to work closely with the USFDA for Clinical Development for Saroglitazar Mg for patients with Primary Biliary Cholangitis (PBC).”

Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses. Fast Track designation can lead to an Accelerated Approval and Priority Review if certain criteria are met.

PBC is a liver disease, caused due to progressive destruction of the bile ducts in the liver which leads to reduction of bile flow – a condition referred to as cholestasis. With an increasing number of people being affected by PBC which can lead to progressive cholestasis and even turn fatal, there is a pressing need to develop therapies which help to achieve an adequate reduction in Alkaline Phosphotase (ALP) or bilirubin, reduce strong side effects of existing drugs such as pruritus or increase in LDL-c and bring in better tolerance and efficacy.

Tags : #Zydus #LatestNewsonZydus9thDec #LatestPharmaNews9thDec #LatestUSFDAFastTrackDesignationnews9thDec #LiverDiseases

About the Author

Team Medicircle

Related Stories

Loading Please wait...


Trending Now

EV Conference 24---Charging Up for e-mobility Minister Ponnam Prabhakar and Jayesh Ranjan among others to graceJune 14, 2024
Are we on track to end AIDS, end viral hepatitis and end STIs by 2030?June 14, 2024
HR Conclave Focusing on Future-Forward Engineering where Engineering and Management students meet their future employees, thus exposing students to real-world HR challenges and innovative solutionsJune 14, 2024
MAGGI Empowers 10 Women to Bring their Entrepreneurial dreams to lifeJune 13, 2024
FTCCI announced its Annual Excellence Awards and invites entries, last date is 20th June 2024June 13, 2024
Bird Flu Cases by Dr Praveen Gupta, Principle Director and Chief of Neurology, Fortis Hospital.June 13, 2024
Sova Health's $1 Million Seed Funding to Drive Gut Health InnovationJune 13, 2024
The Vital Role of Early Detection: Kevin Jonas on Battling Skin CancerJune 13, 2024
Zumutor Biologics Advances Cancer Care with Novel Immunotherapy ZM008: A First-in-Class Anti LLT1 AntibodyJune 13, 2024
HP Ghosh Hospital Unveils Innovative "Chest Tree" June 12, 2024
Olympus Enhances Innovation Capabilities by Expanding R&D to Hyderabad, IndiaJune 12, 2024
From the frontlines: Homeless person won over alcoholism, survived floods and defeated TBJune 12, 2024
The Role of Hormones in Obesity: Why Men and Women Gain Weight DifferentlyJune 12, 2024
Silent Killer: How a Young Mother’s Vision Loss Led to a Lung Cancer DiagnosisJune 12, 2024
TruAlt Bioenergy’s subsidiary, Leafiniti Bioenergy supplies over 1000 tons of Compressed Biogas to AG&P Pratham in just 5 monthsJune 11, 2024
Southeast Asia's Most Advanced Luxury Postpartum Centre Re'Joy Suites Opens in SingaporeJune 11, 2024
Poor Muscle Health in Obesity Can be A Major Risk Factor for Early DeathJune 11, 2024
Machine Learning Uncovers How Organ Ageing Impacts Health and LongevityJune 11, 2024
Why Education is Essential for Health and LongevityJune 11, 2024
New Study Reveals Antidepressant Withdrawal Symptoms Less Common but Still SignificantJune 10, 2024