Zydus, a leading pharma brand, has been granted ‘Orphan Drug Designation’ for one of its drugs by the European Medicines Agency for the treatment of patients with Biliary Cholangitis.
A company spokesperson said on Wednesday that the status has been given to Saroglitazar Mg.
According to the spokesperson, Orphan Drug Designation (ODD) in Europe is given to medicines with the potential to be safe and effective for treatments of rare, life-threatening and chronically debilitating conditions that affect more than 5 in 10,000 people.
The designation gives the companies among various things a wide range of incentives that include assistance with trial protocols, reduced regulatory fees and a 10-year period of market exclusivity if the treatment is eventually approved.
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Earlier, the drug was granted ODD status by the USFDA. It had also got the fast-track designation.
Saroglitazar Mg is a potent and selective peroxisome profilerator –activated receptor alpha and gamma dual agonist.
Pankaj Patel, chairman of the Zydus Group, said that PBC is a serious health condition and that his company is committed in clinical development efforts to improve the quality of life of patients with safe and efficacious treatment.
