A panel of advisors to the US Food and Drug Administration (FDA) recommended on Friday to defer fast-track authorization to the oral drug of Intercept Pharmaceuticals against a type of fatty liver disease, given concerns about the safety of the product.
The review panel decided Majority Votes Deny Approval of Obeticholic Acid Drug (OCA) for the treatment of non-alcoholic fatty liver disease (NASH) and fibrosis, or scarring of the liver, because its benefits do not outweigh the risks in patients, based on current data.
Two members of the commission abstained from the vote.
The treatment of NASH is of enormous interest to the pharmaceutical industrysince there are no approved drugs after numerous clinical failures.
The progressive disease of fatty liver it affects about 5% of adults in the United States, according to the American Liver Foundation.
“If we talk about millions of people with NASH who can take this drug, 1 in 1,000 could suffer severe liver damage due to ingesting the drug; we would be talking about a new epidemic of liver disease due to adverse effectssaid James Floyd, a member of the panel and an adjunct professor at the University of Washington.
The disease is the fastest growing cause for liver transplants in developed nations, as obesity and diabetes increase the risks of NASH.
Intercept’s drug had already been rejected by the FDA in 2020, and the agency determined that the drug’s anticipated effectiveness did not outweigh potential risks.
The drugmaker resubmitted its application last year, with additional analysis of its efficacy and safety, but the FDA did not appear convinced.
“The FDA initially concluded that OCA was associated with an unfavorable risk/benefit profile, and in the new submission our efficacy assessment has not changed.said Ruby Mehta, leader of the FDA’s liver diseases medical team during the meeting on Friday.
The FDA it usually follows the recommendations of its advisory panels, but is not required to do so. The agency had been concerned about the drug’s safety because of signs of an increased risk of diabetes and liver damage, among other adverse effects.
Source: Reuters
Source: Gestion
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