Gilead Sciences (GILD) has received approval from the US Food and Drug Administration for Hepcludex to treat chronic hepatitis delta virus infection in adults without advanced liver scarring, or with compensated cirrhosis, the FDA said Friday.
The therapy is the first FDA-approved treatment for chronic HDV infection, a serious condition that can cause liver fibrosis, liver cancer, liver failure, and even death, the regulator said.
The efficacy of Hepcludex was shown in a phase 3 trial, it said.
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