Generic, brand name and therapeutic class of product

“HIBSAGO (bepirovirsen) injection, for subcutaneous use” (opens the prescribing information at this quote)CopyFlag

“Active ingredient: bepirovirsen sodium” (opens the prescribing information at this quote)CopyFlag

“The drug will now carry the commercial moniker Hibsago” (opens the source at this quote in a new tab)CopyFlag

“The approval was granted to GSK plc.” (opens the source at this quote in a new tab)CopyFlag

“GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection” (opens the source at this quote in a new tab)CopyFlag

“Trademarks are owned by or licensed to the GSK group of companies.” (opens the prescribing information at this quote)CopyFlag

“Manufactured for” (opens the prescribing information at this quote)CopyFlag

“GlaxoSmithKline” (opens the prescribing information at this quote)CopyFlag

“Durham, NC 27701” (opens the prescribing information at this quote)CopyFlag

“Bepirovirsen (previously known as ‘ISIS 505358 or IONIS-HBVRX’) was discovered by and jointly developed with Ionis Pharmaceuticals.” (opens the source at this quote in a new tab)CopyFlag

“Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals in August 2019.” (opens the source at this quote in a new tab)CopyFlag

“GSK licensed bepirovirsen from Ionis and collaborated with them on its development.” (opens the source at this quote in a new tab)CopyFlag

“Bepirovirsen (formerly known as IONIS-HBVRx), also known as GSK3228836, is an investigational antisense medicine designed to reduce the production of viral proteins associated with hepatitis B virus (HBV) infection and replication” (opens the source at this quote in a new tab)CopyFlag

“Hibsago is the first FDA-approved antisense oligonucleotide to treat chronic hepatitis B.” (opens the source at this quote in a new tab)CopyFlag

“Hibsago works by targeting the genetic instructions the virus uses to make copies of itself and viral proteins, helping reduce the amount of virus and hepatitis B surface antigen in the body.” (opens the source at this quote in a new tab)CopyFlag

“Bepirovirsen is a first in class antisense oligonucleotide (ASO) and offers unprecedented functional cure rates compared to current standard of care.” (opens the source at this quote in a new tab)CopyFlag

“Bepirovirsen is a non-GalNAc-conjugated antisense oligonucleotide (ASO) designed to recognize and inhibit the production of the genetic components (i.e., RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person’s immune system to regain control.” (opens the source at this quote in a new tab)CopyFlag

“Bepirovirsen is a synthetic, single-stranded, chimeric antisense oligonucleotide (ASO) with a gapmer architecture consisting of five 2′-O-(2-methoxyethyl) (2′-MOE)-modified ribonucleotide wings flanking a central 10-deoxynucleotide gap with phosphorothioate linkages throughout.” (opens the prescribing information at this quote)CopyFlag

“The molecular formula of bepirovirsen sodium is C230H290N88Na19O115P19S19 and its molecular weight is 7761.9.” (opens the prescribing information at this quote)CopyFlag