--- title: 'Regulatory Daily Summary: What Happened on October 21, 2026' headline: FDA clears GSK’s Hibsago for some adults with chronic hepatitis B description: The FDA also approved Jemperli for selected rectal cancers. UK regulators confirmed long-term access for CE-marked devices and withdrew approval for a chikungunya vaccine. url: https://thebench.bio/news/regulatory/2026-10-21 topic: regulatory date: '2026-10-21' covers: - '2026-10-21' date_published: '2026-10-21T12:04:04Z' date_modified: '2026-10-21T12:04:04Z' tags: - Regulatory - Industry sources: 8 publisher: TheBench.Bio --- # Regulatory Daily Summary: What Happened on October 21, 2026 **FDA clears GSK’s Hibsago for some adults with chronic hepatitis B** The FDA also approved Jemperli for selected rectal cancers. UK regulators confirmed long-term access for CE-marked devices and withdrew approval for a chikungunya vaccine. ## Today in brief GSK’s Hibsago is approved alongside existing antiviral treatment for certain adults with chronic hepatitis B who do not have cirrhosis. [1] [2] Across two trials, 24% of recipients met criteria to stop that treatment, compared with none on placebo. [1] The FDA granted accelerated approval to Jemperli for some locally advanced rectal cancers, offering eligible patients an option that may help them avoid surgery. [3] [4] Great Britain will continue to recognize CE-marked devices, while the MHRA revoked UK approval for Valneva’s chikungunya vaccine Ixchiq. [5] [6] ## Hibsago offers some hepatitis B patients a route off ongoing antivirals The FDA approved GSK’s Hibsago with existing antiviral therapy for certain adults with chronic hepatitis B who do not have cirrhosis. [1] It is the first antisense oligonucleotide the FDA has approved for chronic hepatitis B. [1] The agency also authorized a companion diagnostic to help select and monitor patients. [1] Eligible patients must have taken antiviral therapy for at least six months, have suppressed hepatitis B virus levels, and have a surface-antigen level of 3,000 IU/mL or less. [1] Across two trials, 24% of Hibsago recipients met criteria to stop their existing medicine, compared with none of the placebo recipients. [1] Patients continued their existing medicine for at least 24 weeks after their final Hibsago injection, and injections could be given for up to 24 weeks. [1] Twenty-four weeks after stopping all hepatitis B treatment, 19% of Hibsago recipients had controlled virus and undetectable surface antigen. [1] Hibsago carries a boxed warning for serious liver reactions and low platelet counts, plus warnings for worsening kidney function and serious inflammatory reactions. [1] ## Jemperli wins accelerated approval for selected rectal cancers The FDA granted GSK accelerated approval for Jemperli in adults with stage II or III locally advanced rectal cancer whose tumors are mismatch repair deficient or microsatellite instability-high. [3] [4] The decision relied on interim results from the single-arm Phase II AZUR-1 trial, which enrolled 154 previously untreated patients. [4] [7] At a median follow-up of more than two years, nearly three-quarters of patients had not received surgery, radiation, or chemotherapy. [4] A separate study of 50 patients found no detectable cancer after Jemperli alone, and 93% remained cancer-free at one year. [4] Because the approval is accelerated and based on interim evidence, GSK must provide further clinical data to establish lasting benefit. [4] The label requires an FDA-authorized solid-tumor test to identify the relevant tumor signature. [4] ## UK keeps CE-marked devices eligible for the Great Britain market The UK government confirmed that Great Britain will continue to recognize CE-marked medical devices on a long-term basis. [5] Devices already approved for the European Union market will not need an additional UK approval route under the arrangement. [5] CE marks appear on over nine in ten medical devices registered for use in Great Britain. [5] The consultation ran from February 16 to April 10, 2026, and received more than 1,000 submissions. [5] The MHRA will continue to oversee devices sold in the UK, monitor safety through channels including Yellow Card, and share safety information with international partners. [5] The UKCA pathway remains available as the domestic route. [5] The government is developing legislation to update that pathway and enable a future medical-device licensing approach. [5] ## MHRA revokes UK approval for Ixchiq after safety review The MHRA withdrew Valneva’s UK marketing approval for Ixchiq after reviewing post-marketing information and consulting the Commission on Human Medicines. [6] The agency concluded that the vaccine’s benefits no longer outweighed its risks for chikungunya prevention. [6] UK health professionals can no longer prescribe, supply, or administer Ixchiq, and the MHRA directed that remaining supplies be disposed of. [6] Valneva disagreed with the decision but said it would not appeal. [6] The company plans to continue expanding access in areas where chikungunya is endemic. [6] Vimkunya, made by Bavarian Nordic, is now the other approved chikungunya vaccine in the UK. [6] Adverse-event reports among Ixchiq recipients included three deaths, and analyses indicate the vaccine can cause chikungunya-like illness and rare neurological events such as encephalitis. [6] ## Also worth knowing - The FDA approved Cosette Pharmaceuticals’ Evoxac oral solution for dry mouth in adults with Sjögren’s disease. The company expects US availability by late 2026. [8] ## The day in numbers - **24% vs. 0%**: Share of Hibsago and placebo recipients, respectively, who met criteria to stop existing hepatitis B medicine. [1] - **Nearly three-quarters**: Share of AZUR-1 participants who had not received surgery, radiation, or chemotherapy at median follow-up exceeding two years. [4] ## Also published - [The Therapeutic Areas or Deals That Might Be Negatively Impacted by MFN Deals](), Pharmaceutical Executive - [Jemperli label extended to include rectal cancer](), pharmaphorum ## Sources 1. [FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment](), FDA Press Announcements, 2026-10-20 2. [GSK wins FDA green light for chronic hep B treatment Hibsago](), pharmaphorum, 2026-10-21 3. [GSK’s Jemperli gains rectal cancer approval as rivals advance across colorectal settings](), BioCentury, 2026-10-21 4. [GSK Immunotherapy Gets Accelerated FDA Approval for Treating Rectal Cancer](), MedCity News, 2026-10-20 5. [Government confirms indefinite recognition of CE marked medical devices](), MHRA, 2026-10-21 6. [MHRA revokes approval for Valneva’s Ixchiq due to safety frailties](), Pharmaceutical Technology, 2026-10-21 7. [Pharmaceutical Executive Daily: FDA Grants Accelerated Approval to Jemperli](), Pharmaceutical Executive, 2026-10-20 8. [FDA approves Cosette’s Evoxac oral solution for Sjögren’s disease](), Pharmaceutical Technology, 2026-10-21 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: [5]: [6]: [7]: [8]: