FDA approvals: Hibsago, Jemperli in rectal cancer and Awiqli for children lead the Oct. 17–23 ledger
A date-bounded ledger of the FDA's October 17–23, 2026 decisions, led by the first antisense drug approved for chronic hepatitis B, an accelerated approval that lets some dMMR rectal-cancer patients skip chemotherapy, radiation and surgery, and the first once-weekly insulin for children.
The FDA approved GSK's Hibsago (bepirovirsen) on October 20 for chronic hepatitis B, the first antisense oligonucleotide cleared to treat the infection. 1 Treatment runs six months, on top of the antiviral the patient already takes.
A day earlier the agency granted accelerated approval to GSK's Jemperli (dostarlimab-gxly) for stage II or III rectal cancer carrying a mismatch-repair defect. 2 In the trial behind it, 71% of 154 patients received no surgery, radiation or chemotherapy after the drug. 3
On October 23, Novo Nordisk won approval for Awiqli (insulin icodec-abae) in children 10 and older with type 2 diabetes, the first once-weekly basal insulin for that age group. 4
Three federal data surfaces set what this ledger can see, and each one stopped short of today. FDA's two-week drug approvals report carried entries through October 23. 5
The monthly 510(k) file reached item-level decisions through October 18, leaving October 19–23 without an official device record. 6 The PMA decision feed was rendered October 20 and its newest entry is dated October 16. 7
Those cutoffs pushed five older decisions into this issue. Last week's edition reported the PMA feed's newest decision as October 9, so Vivasure Medical's PerQseal Elite and four efficacy supplements dated October 16 appear here for the first time, carrying their FDA dates.
At a glance
| Action | FDA date | Indication or intended use | Sponsor | What sets its scale |
|---|---|---|---|---|
| Hibsago (bepirovirsen) | Oct. 20 | Chronic hepatitis B, adults without cirrhosis, on antiviral therapy at least six months with HBsAg at or below 3,000 IU/mL | GSK (LSE/NYSE: GSK) | Functional cure in 19% of 1,220 treated patients against none on placebo; GSK expects more than £2 billion in peak annual sales 189 |
| Jemperli (dostarlimab-gxly) | Oct. 19 | Stage II or III locally advanced rectal cancer that is MSI-H or dMMR, previously untreated | GSK | Accelerated approval; 110 of 154 patients avoided surgery, radiation and chemotherapy 23 |
| Awiqli (insulin icodec-abae) | Oct. 23 | Type 2 diabetes in children 10 and older | Novo Nordisk (CPH: NOVO B) | Seven basal injections a week become one; approval rests on adult trials plus an 18-patient pediatric study 410 |
| Skyrizi (risankizumab-rzaa) | Oct. 23 | Moderately to severely active Crohn's disease, subcutaneous induction | AbbVie (NYSE: ABBV) | Clinical remission 56% against 30% at week 12; patients can start treatment at home 11 |
| PerQseal Elite vascular closure device | Oct. 16 | Percutaneous closure of common femoral arteriotomies after catheter procedures using 14–22 F sheaths | Vivasure Medical | An original premarket approval for a large-bore closure device; the label covers 14–22 F sheaths 12 |
| Lightning computer assisted vacuum thrombectomy for DVT | Announced Oct. 20 | Deep vein thrombosis | Penumbra (NYSE: PEN) | Company describes it as the first cleared DVT indication among mechanical thrombectomy devices; no official record yet 13 |
Hepatitis B: a six-month course aimed at functional cure
Hibsago is bepirovirsen, a short synthetic strand of nucleic acid that binds the viral RNA hepatitis B needs to copy itself and make its proteins. 8 GSK licensed the drug from Ionis Pharmaceuticals and developed it with the company. 8
The label covers a narrow group. Patients must be adults without cirrhosis, must have taken a nucleoside or nucleotide antiviral for at least six months, must have suppressed virus in the blood, and must have hepatitis B surface antigen at or below 3,000 IU/mL on an authorized test. 1
Surface antigen, or HBsAg, is the protein that signals hepatitis B infection. The FDA also authorized Roche's Elecsys HBsAg II quant II assay as a companion diagnostic for selecting patients and monitoring them through treatment. 1
Patients inject Hibsago under the skin for up to 24 weeks, with the option of self-injection after the first dose. 1 They keep taking the existing antiviral for at least 24 weeks after the final Hibsago dose. 1
The endpoint that matters is functional cure: virus and surface antigen undetectable at least 24 weeks after every treatment stops. 8 Across the two B-Well trials, 24% of treated patients met the requirements to stop their existing medicine, and none on placebo did. 1
Twenty-four weeks after all therapy ended, 19% still had the virus under control with surface antigen undetectable. 1 Pooled, that is 233 of 1,220 treated patients against 0 of 614 on placebo. 8
Patients who started below 1,000 IU/mL did better: 26% reached functional cure, 200 of 768, against 0 of 393 on placebo. 8 B-Well 1 and B-Well 2 ran in 29 countries and were published in the New England Journal of Medicine. 8
The label carries a boxed warning for serious liver reactions and for low platelet counts, which can cause dangerous bleeding. 1
Warnings also cover worsening kidney function, inflammatory reactions such as vasculitis, and injury from incorrect injection, and patients need blood tests before and during treatment. 1 The most common side effects are injection-site reactions, fever, fatigue and headache. 1
FDA granted Fast Track, Breakthrough Therapy and Priority Review designations. 1
Commercial read
GSK puts the United States population with chronic hepatitis B at about 1.7 million people and the global population above 240 million, with roughly 1.1 million deaths a year from the disease. 8 Reuters reported more than 250 million people worldwide living with the infection. 9
The commercial case rests on a comparison GSK states directly: 19% functional cure from six months of treatment against less than 1% a year on standard antiviral therapy alone. 8 Reuters gives the standard-of-care range as 1% to 4% of patients clearing the virus for a sustained period. 9
GSK expects peak annual sales above £2 billion, or about $2.68 billion, money the company counts toward its plan to reach more than £40 billion in annual revenue by 2031. 9 The drug is already approved in Japan, with China and Europe under review and decisions expected in the coming months. 8
GSK did not answer Reuters' question about US pricing and commercial availability. 9 That leaves the revenue-per-patient half of the model unmodeled until launch terms appear. 9
The label's antigen ceiling shapes the addressable market. Only patients at or below 3,000 IU/mL qualify, and the subgroup below 1,000 IU/mL produced the higher cure rate, so much of the commercial work sits in testing and patient identification rather than in the prescription itself. 18
Ionis, which licensed the drug, is eligible for milestone payments tied to approval and other regulatory benchmarks. 9
The nearest competitor in development is Aligos Therapeutics' pevifoscorvir sodium, in a mid-stage trial. 9
Rectal cancer: an approval that lets patients skip the standard sequence
Jemperli is an antibody against PD-1, a protein on immune cells; blocking it removes a signal that cancer cells use to shield themselves from the immune system. 2
The approval covers adults with previously untreated stage II or III locally advanced rectal cancer whose tumors are mismatch repair deficient or microsatellite instability high, confirmed by an authorized test. 3 Both terms describe the same broken DNA-repair system, which leaves tumors carrying the error-made proteins that immunotherapy recognizes. 2
Standard treatment for this cancer is chemotherapy and radiation followed by surgery, and the surgery can leave patients with permanent bowel, urinary or sexual dysfunction, and sometimes a permanent colostomy. 2
Patients in the registrational trial, AZUR-1, received dostarlimab alone, 500 mg every three weeks for nine cycles, about six months of treatment. 3 Response was judged by combining endoscopy, rectal MRI and CT scans; patients who reached a clinical complete response entered close monitoring instead of surgery. 3
Of 154 treated patients, 110 (71%) took dostarlimab alone, needed no other treatment and had no disease progression. 3 Another 26 patients (17%) went to surgery, 13 (8%) received further systemic therapy or radiation, and four withdrew or were lost to follow-up. 3
Among 116 patients the central reviewers could assess, 47% held a clinical complete response for 12 months. 3 Investigator assessment put that figure at 68%, and 33% more patients had reached a complete response but had less than 12 months of follow-up at the data cutoff. 3 The overall response rate by central review was 79%. 3
FDA also reviewed an investigator-led 50-patient study at Memorial Sloan Kettering, where the 12-month complete-response rate was 93% and every patient responded. 3 Of 27 patients followed for at least three years, one had a local recurrence treated with lymph node surgery. 3
Serious adverse reactions occurred in 20% of patients, and 3% stopped treatment permanently because of side effects. 14 The most common were fatigue (32%), rash (22%), diarrhea (18%) and itching (17%). 14 The label warns of immune-mediated reactions that can be severe or fatal. 3
This is an accelerated approval. Continued approval may depend on confirmatory trials showing the responses produce lasting benefit, and the long-term risk of relapse is unknown. 14 GSK said full AZUR-1 interim data will be presented at the European Society for Medical Oncology congress in October 2026. 14
Commercial read
GSK and the FDA describe the eligible population at different sizes. 2 The FDA cites published estimates that about 3% of locally advanced rectal cancers are dMMR or MSI-H; GSK puts the share at 5% to 10% of rectal cancers. 14 Analysts modeling the launch have to pick one of those denominators.
The size of the opportunity depends on biomarker testing at diagnosis, since a patient who is never tested cannot be steered to the drug. 14 The Colorectal Cancer Alliance made that point in its comment on the approval, calling testing at diagnosis essential to finding eligible patients. 14
The FDA reviewed the application under its National Priority Voucher pilot and approved it about four months ahead of its goal date. 3 It was the eleventh approval under that pilot program. 2
Review ran in parallel with Health Canada, Israel's Ministry of Health, Swissmedic and the UK's MHRA under Project Orbis, with those reviews still open. 3
Patients who reach a clinical complete response enter surveillance in place of surgery. In the trial that meant assessments every four months for two years, then every six months. 3
Diabetes: a weekly insulin reaches children
Awiqli is insulin icodec, a long-acting insulin analog that holds blood glucose down across a weekly dosing interval. 4 The approved use is glycemic control in children 10 and older with type 2 diabetes, alongside diet and exercise, at a single concentration of 700 units per milliliter in the Awiqli FlexTouch pen. 10
The pediatric label rests on extrapolation from adult data. FDA describes a single-dose study in 18 children aged 10 and older with type 2 diabetes: they absorbed the first dose faster than adults, and modeling showed blood levels converging on adult levels after the first few doses. 4
Novo points to the adult ONWARDS program for the efficacy and safety evidence behind the pediatric use. 10
The safety profile matches other insulins, with hypoglycemia the most common reaction. 4 The label also warns about medication errors and accidental overdose, because the dosing differs from daily insulins. 4
Commercial read
Novo's case for the pediatric label rests on numbers. 10 Novo cites a modeling study projecting that the number of people aged 19 and under with type 2 diabetes in the United States will approach 84,000 by 2050. 10
Awiqli was already available for adults, so the pediatric approval extends an existing product into a group where daily injections fall to a parent or a child's own routine. 4 Novo says the drug is stocked at more than 70,000 pharmacies, which removes the distribution build a new product would need. 10
Crohn's disease: the same drug, started at home
AbbVie won approval on October 23 for a subcutaneous induction regimen of Skyrizi in adults with moderately to severely active Crohn's disease. 11
Induction is 720 mg through an on-body injector at weeks 0, 2, 4 and 8, and maintenance continues with the same injector every eight weeks from week 12. 11 The intravenous option, 600 mg at weeks 0, 4 and 8, remains. 11
The supporting trial, AFFIRM, randomized 274 patients two to one to subcutaneous Skyrizi or placebo, and 65% had already failed an advanced therapy. 11 At week 12, clinical remission was 56% against 30% on placebo, and endoscopic response 43% against 15%. 11
In patients who had never failed a biologic or JAK inhibitor, remission reached 74% against 27% and endoscopic response 60% against 15%. 11
The same decision changed the warning language across all of Skyrizi's indications, letting doctors use clinical judgment on whether tuberculosis testing is needed before starting. 11
Commercial read
In Crohn's disease, induction has been the part of treatment that pulls patients into an infusion center. 11 The approval removes that visit for eligible patients and lets a prescriber start and continue the same injector. 11
AbbVie's supporting survey data points the same way: 88% of 186 patients rated the on-body injector easy to use, and 87% of 352 adults with inflammatory bowel disease were satisfied with it against 71% for an autoinjector. 11 Those are company-commissioned surveys rather than trial endpoints. 11
Other captured drug actions
The rest of the window's drug record is generic original applications, two new-ingredient filings from Fresenius Medical Care and labeling updates. 5
| Application | Product | Applicant | Date | What FDA's record shows |
|---|---|---|---|---|
| NDA 221276, ORIG-1 | Hibsago (bepirovirsen) | GlaxoSmithKline | Oct. 20 | Type 1 new molecular entity, priority review, breakthrough therapy 5 |
| NDA 219455, ORIG-1 | Cienby (sodium citrate) injection | Fresenius Medical Care | Oct. 19 | Type 2 new active ingredient 5 |
| NDA 219456, ORIG-1 | Calrezdy (calcium chloride) injection | Fresenius Medical Care | Oct. 19 | Type 2 new active ingredient 5 |
| BLA 761136, SUPPL-17 | Reblozyl (luspatercept-aamt) | Celgene | Oct. 20 | Labeling supplement 5 |
| NDA 202231, SUPPL-10 | Levothyroxine sodium injection | Fresenius Kabi USA | Oct. 21 | Labeling supplement, the only drug action FDA posted that day 5 |
| ANDA 221301, ORIG-1 | Brivaracetam oral solution | Zydus Lifesciences | Oct. 20 | Generic original application 5 |
| ANDA 217103, ORIG-1 | Deflazacort tablets | Teva Pharms | Oct. 19 | Generic original application 5 |
| ANDA 218930, ORIG-1 | Eribulin mesylate injection | Kindos | Oct. 19 | Generic original application 5 |
| ANDA 210142, ORIG-1 | Apixaban tablets | Teva Pharms USA | Oct. 19 | Tentative approval 5 |
| BLA 761174, SUPPL-15 | Jemperli (dostarlimab-gxly) | GlaxoSmithKline | Oct. 19 | Efficacy supplement for a new indication, the rectal cancer approval above 15 |
Four efficacy supplements first appeared in this week's report for October 16, after last week's issue went out. 5 FDA's report records each as an efficacy supplement without naming the new claim.
| Application | Product | Applicant | Date | What FDA's record shows |
|---|---|---|---|---|
| BLA 125514, SUPPL-191 | Keytruda (pembrolizumab) | Merck Sharp & Dohme | Oct. 16 | Efficacy supplement 5 |
| BLA 761467, SUPPL-8 | Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) | Merck Sharp & Dohme | Oct. 16 | Efficacy supplement 5 |
| NDA 212608, SUPPL-21 | Ayvakit (avapritinib) | Blueprint Medicines | Oct. 16 | Efficacy supplement 5 |
| NDA 217064, SUPPL-5 | Ryzumvi (phentolamine mesylate ophthalmic solution) | FamyGen Life Sciences | Oct. 16 | Efficacy supplement 5 |
What changed in those four labels sits in the prescribing information on Drugs@FDA, which each application's record links.
Devices: what the official files carry, and what only the companies announced
The current 510(k) downloadable file carries 51 decisions dated October 13 through 18, the first item-level device records for that stretch. 6 Last week's issue reported that no official record existed for October 12–16. Those decisions are now in the file, which also carries one dated October 18. 6
Four clearances in that batch stand out for what the device is. 6
Intuitive Surgical cleared the da Vinci 5 handheld camera head, along with 0- and 30-degree camera laparoscopes, on October 14. 6 Deka Research and Development cleared the twiist Loop Algorithm on October 15, and THINK Surgical cleared the TMINI miniature robotic system on October 16. 6
CorDx cleared an at-home multiplex rapid test for influenza A and B and COVID-19 on October 14. 6
The same batch includes Masimo's Radius VSM monitoring system on October 14, Life Technologies' Oncomine Dx Express Test on October 15, and Shenzhen Mindray's Nuewa A20 ultrasound family on October 16. 6
One original device approval also reached the public ledger this week. 7
Vivasure Medical's PerQseal Elite Vascular Closure Device won premarket approval on October 16 for closing common femoral arteriotomies after catheter procedures that used 14 to 22 French sheaths, or arteriotomies up to 26 French. 12 The company, based in Galway, Ireland, filed the application in June 2025, and the PMA cites a clinical trial registered as NCT04818541. 16
Sheaths that wide carry the catheters used in structural heart and other endovascular procedures, and the PMA record sets the device's job as closing the puncture afterwards. 12
The other 24 PMA decisions dated October 16 are supplements, and the feed carries no decision dated October 17 or later even though it was rendered on October 20. 7
Three device clearances were announced between October 19 and 23 without any official record yet.
| Product | Applicant | Announced | What the company says it is cleared for |
|---|---|---|---|
| Lightning computer assisted vacuum thrombectomy for DVT | Penumbra | Oct. 20 | Treatment of deep vein thrombosis, described as the first cleared DVT indication among mechanical thrombectomy devices 13 |
| Restrata Matrix used with V.A.C. Therapy | Solventum, which acquired Acera Surgical in December 2025 | Oct. 19 | Combined use of a synthetic resorbable wound matrix with negative pressure wound therapy 17 |
| CORE 300 digital stethoscope | Eko Health | Oct. 22 | Digital and analog listening in one chestpiece with AI murmur detection, for children and adults; clearance listed as K261694 18 |
Penumbra's DVT clearance rests on BOLT-DVT, a prospective single-arm trial in iliofemoral clots. 13
The company reports complete or near-complete clot removal in 98% of patients, a median device time of 18 minutes, a 3.1% rate of major adverse events at 48 hours and re-thrombosis in 3.9% within 30 days. 13 Penumbra cites about 900,000 cases of venous thromboembolism a year in the United States, a figure that covers deep vein thrombosis and pulmonary embolism together. 13
Penumbra's own release notes a pending acquisition by Boston Scientific among the risks to its outlook. 13 This week's action adds a venous claim to the same CAVT aspiration platform the company developed for clot removal. 13
What matters next
GSK has yet to disclose Hibsago's US price or launch date, and regulatory decisions in China and Europe are due in the coming months. 8
Jemperli's accelerated approval obliges GSK to keep following AZUR-1 patients, and the full interim analysis is scheduled for the ESMO congress in October 2026. 14
Awiqli's pediatric label covers ages 10 and older, and the evidence behind it is adult efficacy data plus the 18-patient pharmacokinetic study. 4
Device records for October 19–23 will appear when the monthly 510(k) file is refreshed, and the PMA feed has yet to publish any decision later than October 16. 67
The four October 16 efficacy supplements, including two for Keytruda, need their labels read directly on Drugs@FDA to establish what changed. 5
References
- 1
- 2
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- 4
- 5Recent New and Generic Drug Approvals
accessdata.fda.gov
- 6Downloadable 510(k) Files
fda.gov
- 7FDA PMA Decisions Feed
accessdata.fda.gov
- 8
- 9
- 10
- 11
- 12
- 13
- 14
- 15Drugs@FDA record for BLA 761174, Jemperli (dostarlimab-gxly)
accessdata.fda.gov
- 16
- 17
- 18
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