NICE Recommends Gilead’s Bulevertide for Hepatitis Delta Virus

The UK’s National Institute for Health and Care Excellence (NICE) has announced its approval of Gilead Sciences’ bulevirtide for the treatment of hepatitis delta virus (HDV) in adults with compensated liver disease. This recommendation comes after the US Food and Drug Administration (FDA) shot down Gilead’s application for issues with manufacturing and delivery.

According to Kevin Dunleavy, “The entry inhibitor received orphan-drug status in the U.S. in 2015 and was launched in Europe under the brand name Hepcludex in September 2020 after it received a conditional endorsement. Earlier this month, Europe’s Committee for Medicinal Products for Human Use recommended bulevirtide for full marketing authorization. The nod came after a phase 3 study showed significant viral declines for patients after 48 weeks of treatment.”

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(Source: Fierce Pharma, May 15^th, 2023)