Article author:
Reuters
Intercept Pharmaceuticals Inc will resubmit its application for approval of a treatment for chronic liver disease to the US Food and Drug Administration two years after regulatory denial of approval.
The company aims to treat fibrosis or scars associated with non-alcoholic fatty hepatitis (NASH), a serious progressive liver disease caused by the accumulation of excess fat in the liver. We are seeking approval for obeticolic acid.
Intercept, based on an interim analysis, stated that the treatment had a statistically significant reduction in fibrosis in NASH patients after 18 months compared to placebo.
However, analysts were skeptical about the latest data and the commercial potential of the drug.
Jefferies analyst Michael Yee said the new data did not add anything new to what investors know about treatment. "Overall, we expect investors to continue to question NASH's commercial opportunities."
The FDA says that expected profits are still uncertain and potential risks. He refused to approve treatment in 2020, stating that it was not well above. (https://reut.rs/3uy0Ysl)
At that time, the FDA recommended that Intercept submit additional data from late-stage studies.
According to American Liver, about adults in the United States 5% have NASH. The Foundation has a favorable opportunity for pharmaceutical companies as giants such as Novo Nordisk and Pfizer are developing treatments.
Intercept treatments are , Already approved for another chronic liver disease called primary biliary cholangitis (PBC).
{35 B. Riley Securities analyst Mayank Mamtani said the FDA for the company to navigate. He said the security and profit framework of the PBC remains difficult, adding that some investors would prefer capital allocation while focusing on the commercialization of PBC in the United States.Equities. The company was flat at $ 15.28.
(reported by Bengalur's Mrinalika Roy and Leroy Leo, edited by Vinay Dwivedi and Krishna Chandra Eluri)
