FDA Approves GSK’s Hibsago for Chronic Hepatitis B

Pharmexec reports that the FDA has approved GSK’s Hibsago, which the publisher describes as the first functional-cure therapy for chronic hepatitis B.

The regulatory decision appeared in Pharmaceutical Executive Daily coverage that also included findings from an ICER and West Health report on drug launch prices and news that CSL named Deborah Waterhouse as CEO and managing director.

FDA decision on Hibsago

According to Pharmexec, GSK’s Hibsago has received FDA approval for chronic hepatitis B. The publisher characterized Hibsago as the first functional-cure therapy for the condition.

The approval is the lead regulatory development in the publisher’s daily update. For pharmaceutical and biotechnology sales professionals, the report identifies a new FDA milestone involving chronic hepatitis B and GSK’s Hibsago.

Pharmexec’s summary does not provide additional details on the therapy, the FDA decision, or the treatment’s use. The reported facts are that the FDA approved Hibsago, that GSK is associated with the therapy, and that Pharmexec described it as the first functional-cure therapy for chronic hepatitis B.

Other items in the daily update

Alongside the Hibsago news, Pharmexec cited an ICER and West Health report finding that median drug launch prices climbed to $257,000.

The same daily update reported that CSL named Deborah Waterhouse as CEO and managing director. These reports appeared together in the publisher’s coverage, bringing regulatory news, pricing research, and a biopharma leadership announcement into one update.

Key points reported by Pharmexec

• The FDA approved GSK’s Hibsago.
• Pharmexec described Hibsago as the first functional-cure therapy for chronic hepatitis B.
• An ICER and West Health report found median drug launch prices climbed to $257,000.
• CSL named Deborah Waterhouse as CEO and managing director.