FDA grants accelerated approval for Gilead’s Hepcludex
The US Food and Drug Administration (FDA) has granted accelerated approval for Gilead Sciences’ (Nasdaq: GILD) Hepcludex (bulevirtide-gmod) 8.5mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the USA, and sending the firm’s shares up 3% to $134.36 by close on Friday.
Friday's regulatory green light comes about four years after the FDA initially rejected the drug due to concerns about manufacturing and how it is given to patients. Continued approval for the approved indication may be contingent on verification and description of clinical benefit in a confirmatory trial.
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