(RTTNews) - Pharmaceutical firm Gilead Sciences, Inc. (GILD), on Friday, said it has submitted a Biologics License Application or BLA, to the U.S. Food and Drug Administration or FDA, for bulevirtide 2 mg injection, a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus or HDV infection in adults with compensated liver disease.
The bulevirtide has already been granted Breakthrough Therapy and Orphan Drug designations, the company said in a statement.
Bulevirtide is an investigational agent in the U.S. and its safety and efficacy have not been established so far. The BLA submission is supported by data from completed and ongoing phase two studies and the ongoing phase three MYR301 study which supports the safety and efficacy of bulevirtide 2 mg.
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