2023-06-25 23:04:26
▲ FDA approval of a non-alcoholic fatty liver treatment developed by Intercept was suspended. (Photo = DB)
[메디컬투데이=이승재 기자] The US Food and Drug Administration (FDA) approval of a non-alcoholic fatty liver treatment developed by Intercept has been withheld.
Intercept Pharmaceuticals announced on the 22nd (local time) that its non-alcoholic fatty liver (NASH) treatment has not received FDA approval.
Non-alcoholic fatty liver disease has a prevalence of 5% in adults in the United States, and many pharmaceutical companies have attempted to develop treatments for it, but it has failed every time.
With the FDA’s decision, Intercept has suspended all investments in non-alcoholic fatty liver disease and has decided to focus its investments on other liver diseases, particularly rare liver diseases.
In May, the FDA’s advisory panel recommended that approval of the treatment should be withheld until Intercept’s later study data is available, and this is expected to have influenced the FDA’s decision this time.
As a result, Intercept’s share price fell more than 11%.
Reporter Lee Seung-jae of Medical Today ([email protected])
[저작권자ⓒ 메디컬투데이. 무단전재-재배포 금지]
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