Under the deal, Gilead will acquire Hepcludex, which has been conditionally approved by the European Medicines Agency to treat chronic HDV infection in adults with compensated liver disease. Hepcludex is the first and only drug conditionally approved by the EMA to treat chronic HDV.
Gilead expects to file for approval of the drug with the FDA in the second half of 2021. The agency has already granted the drug orphan drug and breakthrough therapy status.
“HDV is a devastating disease with high unmet medical need. With Hepcludex, we have the opportunity to address that need with a first-in-class therapy,” said Daniel O’Day, Gilead’s CEO.
Read the full news release here.
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