Twice-Yearly Shot for a Severe Type of Asthma

Exdensur (depemokimab; in the United States, depemokimab-ulaa; pronounced Ex-DEN-shur) is a humanized IgG1 kappa monoclonal antibody that binds interleukin-5 (IL-5). A YTE change in the Fc region lengthens half-life so the labelled dose is 100 mg under the skin once every 6 months (26 weeks). It is add-on maintenance, not a rescue inhaler and not a cure.

The United States labelled it for severe eosinophilic asthma in people 12 and older — not for nasal polyps. Health Canada, the UK MHRA, the European Commission, Japan’s MHLW, and the Australian PI include adult chronic rhinosinusitis with nasal polyps (CRSwNP) as a second indication. China’s company NMPA note is asthma only, with polyps still under review on that announcement.

This is not a steroid replacement you start by stopping everything else. Labels warn against abrupt corticosteroid withdrawal and against using the injection for sudden breathing trouble.

Where this is taking place

Pivotal trials are finished. Access in labelled countries is a commercial prescription, not a new enrolment slot. Historical Canadian sites on SWIFT/ANCHOR/AGILE are not a clinic directory.

SWIFT-1 (NCT04719832) — Phase 3, 52 weeks, severe eosinophilic asthma, ages 12+. Status COMPLETED (CT.gov verified Nov 2024). Sponsor: GlaxoSmithKline. 123 locations / 12 countries. Canadian sites on CT.gov (facility name “GSK Investigational Site” only — no PI): Ajax ON L1S 2J5; Niagara Falls ON L2H 1H5; Ottawa ON K1G 6C6; Windsor ON N8X 1T3; Québec QC G1G 3Y8. Countries also include China, Czechia, France, Germany, Ireland, Italy, Poland, Russia, Spain, the United Kingdom, and the United States.

SWIFT-2 (NCT04718103) — Replicate Phase 3 asthma trial. Status COMPLETED (verified Nov 2024). 129 locations / 11 countries. Canadian sites: Sherwood Park AB T8H 0N2; Kamloops BC V1Y 4N7; Burlington ON L7N 3V2; Québec QC G1V 4W2; Windsor (CT.gov zip printed as 5000). Also Australia, Czechia, France, Hungary, Italy, Japan, Poland, Spain, Taiwan, United States.

ANCHOR-1 (NCT05274750) — Phase 3 adult CRSwNP. Status COMPLETED (verified Nov 2025). 105 locations / 11 countries. Canadian sites: Hamilton ON L8L 2X2; London ON N6A 4V2; Ottawa ON K1H 1E4; Montreal QC H2V 2K1 and H2X 3E4; Québec QC G1S 4L8 and G1V 4W2.

ANCHOR-2 (NCT05281523) — Replicate Phase 3 CRSwNP. Status COMPLETED (verified Aug 2025). 84 locations / 9 countries. No Canadian sites on CT.gov. Countries: China, Italy, Japan, Poland, Romania, Spain, Sweden, Türkiye, United States.

AGILE (NCT05243680) — Open-label asthma extension after SWIFT. Status COMPLETED (verified Dec 2025). Canadian sites: Sherwood Park AB; Kamloops BC V2C 5T1; Ajax ON; Ottawa ON K1G 6C6.

Pipeline trials (EGPA OCEAN NCT05263934, HES DESTINY NCT05334368, COPD ENDURA/VIGILANT) are not labelled uses. They are not this Access Level.

Commercial supply (labelled): United States (asthma only), Canada (asthma + adult CRSwNP, marketed), United Kingdom (asthma + adult CRSwNP), European Union (asthma + adult CRSwNP), Japan (asthma + CRSwNP), Australia (PI: asthma + adult CRSwNP). China: company NMPA, asthma.

Approval matrix

Access by country

• United States: Allergist, pulmonologist, or severe-asthma clinic. FDA-labelled 16 Dec 2025 for people 12+ with severe eosinophilic asthma not controlled on current maintenance medicines. 100 mg SC every 6 months, given by a healthcare provider — the USPI does not authorise home self-injection. Nasal polyps are not on the US label. Prior authorization still applies. GSK US patient line on the Patient Information leaflet: 1-833-EXDENSUR / www.EXDENSUR.com. Adverse events: GSK 1-888-825-5249 or FDA MedWatch. No copay dollars here. Do not treat a Canadian or EU polyps script as a US indication.

• Canada (zoom): Authorized and marketed (DIN 02568934; PM 15 Jun 2026). Two labelled uses: severe eosinophilic asthma, 12+, add-on when medium- to high-dose ICS plus another controller is not enough; and adult severe CRSwNP with INCS when systemic steroids and/or surgery are not enough. Ask the asthma or rhinology specialist for a prescription. Pen or syringe may be self-injected after training — that is the Canadian monograph, not the USPI. Authorized ≠ funded. CDA-AMC SR0926-000 (asthma) and SR0934-000 (CRSwNP) are Active; expert committee 23 Sep 2026 is scheduled — not a recommendation yet. Provincial / territorial / NIHB / RAMQ listing unknown. SAP is the wrong door for a labelled, marketed product. GSK Canada: 1-800-387-7374 (PMI) — medical information, not a copay program. Do not mail-order a US asthma-only bottle for Canadian polyps.

• United Kingdom: MHRA authorised 15 Dec 2025 for asthma 12+ (type 2 / eosinophilic phenotype on maximum moderate- or high-dose ICS plus another controller) and adult severe CRSwNP. Pen PL 19494/0328. Syringe PL 19494/0329. NICE GID-TA11553 is suspended. TA1123 polyps is terminated. Not a yes. No NHS routine funding from those appraisals. Ask the severe-asthma or ENT clinic. SmPC on emc. GSK UK medical information 0800 221 441 / ukmedinfo@gsk.com (emc).

• European Union: EC licence 12 Feb 2026. Asthma 12+ with type 2 inflammation characterised by blood eosinophil count, inadequately controlled on high-dose ICS plus another controller; adult severe CRSwNP. Prescribed by a clinician experienced in asthma or CRSwNP. Self-injection allowed if trained. National reimbursement will lag the licence. Additional monitoring (black triangle). Do not treat CHMP (11 Dec 2025) as the licence — the Commission date is 12 Feb 2026.

• Japan: In-country commercial after MHLW 22 Dec 2025. Asthma (severe or refractory, uncontrolled on existing treatment) in people 12+; CRSwNP inadequately controlled on standard treatment in adults. 100 mg every 26 weeks. Company launch 15 Apr 2026. NHI unknown here. Not a Canadian or US travel path, and not the US label.

• China: In-country commercial per GSK for severe eosinophilic asthma 12+. NMPA page not retrieved. Polyps still under review on the company note. NRDL not found. Not a Canadian travel path.

• Australia: AU PI first approval 24 Jul 2026 — asthma 12+ and adult CRSwNP. ARTG ID and PBS status unknown. Specialist + local funding rules.

• Switzerland: Authorisation not confirmed on documents checked. Specialist + local special-access / trial if those programs apply.

If your regulator has not authorised the use you need: do not import on your own. US polyps is not a labelled use. Travelling to a polyps-labelled market (Canada, UK, EU, Japan, Australia on the PI) is a plan with both specialists, not a DIY order.

Who is eligible (from the labels — they are not the same)

This is an eosinophilic / type 2 conversation. Use the label of the country that will prescribe. Eosinophil cut-offs are not the same on every label.

United States (USPI):

• Age 12 years or older.
• Severe asthma characterized by an eosinophilic phenotype (the indication sentence has no printed cell-count floor).
• Add-on maintenance. Not for sudden bronchospasm or status asthmaticus.
• SWIFT evidence population (USPI §14; trial, not a printed indication number): blood eosinophils ≥150 cells/mcL at screening or ≥300 cells/mcL in the year before entry; ≥2 exacerbations needing systemic steroids in the prior year on medium- to high-dose ICS plus another controller; reduced FEV1.
• Dose: 100 mg SC every 6 months, healthcare provider.
• Nasal polyps: not labelled.
• Children under 12: not established.

Canada (Product Monograph 15 Jun 2026):

• Asthma: adults and adolescents 12+; severe asthma, eosinophilic phenotype; inadequately controlled by medium- to high-dose ICS plus another asthma controller. Not for acute bronchospasm or status asthmaticus. Indication has no printed cell-count floor. SWIFT trial floor on the PM: ≥150 cells/mcL at screening or ≥300 cells/mcL in the 12 months prior.
• CRSwNP: adults only; severe disease; add-on to intranasal corticosteroids; inadequately controlled by systemic corticosteroids and/or surgery. Under-18 not established.
• Same dose: 100 mg SC every 6 months. Self-inject if trained.
• Hypersensitivity to depemokimab or any ingredient is a contraindication.

European Union (EPAR SmPC):

• Asthma: adults and adolescents 12+; severe asthma with type 2 inflammation characterised by blood eosinophil count; inadequately controlled despite high-dose ICS plus another controller (see 5.1). Section 5.1 trial text uses >150 cells/mcL at screening or >300 cells/mcL in the prior year — that is not the same punctuation as the US/HC ≥ floors.
• CRSwNP: adults; severe; add-on INCS; systemic corticosteroids and/or surgery not enough.
• Hypersensitivity contraindication. Self-admin if trained. Reassess at least annually.

United Kingdom (emc SmPC):

• Asthma: 12+; type 2 inflammation characterised by an eosinophilic phenotype; inadequately controlled on maximum moderate-dose or high-dose ICS plus another controller.
• CRSwNP: adults; severe; add-on INCS; SCS and/or surgery not enough.
• Trial floor in SmPC 5.1: ≥150 / ≥300, aligned with US/HC trial text, not the EMA “>” line.

Japan (PMDA review / Japanese indication, not the US label):

• Bronchial asthma limited to severe or refractory patients whose symptoms cannot be controlled with existing treatments; adults and children 12+.
• CRSwNP limited to patients inadequately controlled with standard treatment; adults.
• Do not import a US cell-count sentence onto the Japanese line without the Japanese PI.

China (company NMPA until nmpa.gov.cn):

• Severe asthma, eosinophilic phenotype, 12+. Polyps not on the company asthma announcement.

Not labelled:

• Acute asthma attack / status asthmaticus.
• US CRSwNP.
• Asthma under 12 anywhere checked.
• CRSwNP under 18.
• EGPA, HES, COPD (pipeline trials only).
• Stopping all inhalers the day the injection starts.

What the pivotal studies showed (label vs journal)

Use the label of the country that will prescribe. Secondary endpoints that missed statistical hierarchy are not a “lung function win.”

SWIFT-1 / SWIFT-2 (asthma, USPI / EMA / HC — same primary numbers):

• Annualized clinically significant exacerbations over 52 weeks.
• SWIFT-1: 0.46 vs 1.11 per year; rate ratio 0.42 (95% CI 0.30–0.59); p<0.001.
• SWIFT-2: 0.56 vs 1.08; rate ratio 0.52 (95% CI 0.36–0.73); p<0.001.
• Share of patients with an exacerbation: 32% vs 46% (SWIFT-1) and 32% vs 50% (SWIFT-2).
• Hospital/ED exacerbations were numerically lower (USPI: 1% and 4% vs 8% and 10%). EMA notes a pooled 72% reduction as a secondary/nominal analysis — it is not the primary endpoint.
• Lung function and ACQ-5: USPI treatment difference in pre-bronchodilator FEV1 −1 mL (SWIFT-1) and +56 mL (SWIFT-2) vs placebo; ACQ-5 responders ~54% on both arms. EMA overview: no difference vs placebo on SGRQ, ACQ-5, or FEV1. UK SmPC: SGRQ failed the hierarchy, so later secondaries are not confirmatory. This is exacerbation reduction, not a proven quality-of-life or FEV1 win.

ANCHOR-1 / ANCHOR-2 (CRSwNP — not a US labelled use):

• Co-primary: endoscopic nasal polyp score at week 52 and nasal-obstruction VRS over weeks 49–52.
• EMA overview: polyp score improved 0.5 points on drug vs worsened 0.1 on placebo; obstruction improved 0.8 vs 0.5.
• SmPC: ANCHOR-1 polyp difference −0.7 (95% CI −1.1, −0.3); ANCHOR-2 −0.6 (−1.0, −0.2). Obstruction differences −0.23 and −0.25.
• Secondary hierarchy broke (rhinorrhoea). Surgery/steroid-sparing analyses were not the confirmatory primary.

NEJM / Lancet are journals. They do not expand a country’s indication.

How it is taken (labelled)

100 mg in 1 mL, subcutaneous, once every 6 months (every 26 weeks), into the upper arm, thigh, or abdomen, staying 5 cm / 2 inches off the navel. Refrigerate 2–8 °C. Do not freeze or shake. Unopened carton may sit at room temperature up to 30 °C for 7 days; once out of the carton, use within 8 hours. Sit 30 minutes at room temperature before injecting. Colourless to yellow to brown, clear to opalescent; air bubble is normal.

United States: a healthcare provider gives the prefilled syringe (USPI).
Canada / EU / UK: prefilled pen or syringe; adult or adolescent (asthma) or caregiver may inject after training if the clinician agrees.

Missed dose: give as soon as possible. If 1 month or more late (Canada/EU/UK), restart the 6-month clock from the day you give the late dose. USPI: give the missed dose as soon as possible and resume q6-month from that date.

This is long-term add-on. EU SmPC: decide at least yearly whether to continue.

Safety (from the labels)

Do not use for acute bronchospasm or status asthmaticus. Seek care if asthma stays uncontrolled or worsens.

Hypersensitivity, including anaphylaxis. USPI: can occur; discontinue and treat. EU/UK/Canada: hypersensitivity is a contraindication; delayed reactions (hours to days) are described. Swelling of face/tongue, breathing trouble, rash, hives, dizziness → emergency care.

Helminth (parasitic worm) infection. Eosinophils help fight some worms. Treat existing infection before starting. If a new infection does not respond to anti-helminth treatment: USPI — discontinue until the infection resolves; EU/UK/Canada — consider delaying the next dose until it resolves. Those are not the same instruction.

Do not stop inhaled or systemic steroids abruptly. Taper only under a clinician.

USPI most common adverse reactions (≥4% and more common than placebo, SWIFT pooled): upper respiratory tract infection 9% vs 8%; allergic rhinitis 6% vs 3%; influenza 5% vs 4%; arthralgia 4% vs 3%; pharyngitis 4% vs 1%. Injection-site reactions 1%.

EU/UK SmPC most common: local injection-site reactions (common, ~1–2%); pruritus; administration-related non-allergic reactions (headache, fatigue, rash). GOV.UK news “more than 1 in 10” line is not the SmPC table — follow the SmPC.

Canadian PM also flags liver-enzyme events (2% vs 1% needing discontinuation or extra monitoring in pooled SWIFT+ANCHOR) without an established causal link; USPI does not box hepatotoxicity.

Pregnancy: monoclonal antibodies cross the placenta more in later pregnancy; the YTE change may prolong infant exposure. USPI: report exposure at 1-888-825-5249. EU: preferable to avoid. Canada: do not use unless benefit justifies risk; tell the clinician if pregnancy occurs during treatment or within 8 months after stopping.

Under 12 (asthma) and under 18 (CRSwNP): not established.

Research team (Who)

Names below appear on NCT, label, PM, EPAR, NEJM, or Lancet. CT.gov overall official is GSK Clinical Trials, not a hospital PI.

• GlaxoSmithKline / GSK — sponsor (SWIFT, ANCHOR, AGILE). US BLA holder: GlaxoSmithKline LLC, Philadelphia, PA, U.S. License No. 1727; distributed Durham, NC. Canada MAH: GlaxoSmithKline Inc., Mississauga. UK MAH: GlaxoSmithKline UK Limited, London (PL 19494/0329). EU MAH: GlaxoSmithKline Trading Services Limited, Dublin. Japan MAH: グラクソ・スミスクライン株式会社.
• GSK Clinical Trials — study director on NCT04719832, NCT04718103, NCT05274750, NCT05281523, NCT05243680.
• David J. Jackson, FRCP, MSc, PhD — NEJM SWIFT first / lead author; Guy’s Severe Asthma Centre, Guy’s and St Thomas’ NHS Foundation Trust, and King’s College London (as in the SWIFT byline / subsequent pooled paper). Not named as CT.gov “overall official.”
• Philippe Gevaert; Joseph K. Han; ANCHOR-1 and ANCHOR-2 trial investigators — Lancet 2025;405:911-926 byline (Gevaert P, Desrosiers M, Cornet M, Mullol J, De Corso E, et al.).
• Martin Desrosiers — Lancet co-author (byline). Canadian ANCHOR-1 sites on CT.gov list facility names only.
• IQVIA Pty Ltd — SWIFT collaborator (CT.gov).

No Canadian principal investigator is named on these CT.gov records.

How to talk to a doctor

Bring the NCT numbers and the label of the country you are in.

1. “Is my asthma severe eosinophilic / type 2, and has my blood eosinophil count been documented? Which country’s floor are we using — the US/Canada trial ≥150 or ≥300, or the EU SmPC >150 / >300?”
2. “I am 12 or older. Is Exdensur (depemokimab) 100 mg under the skin every 6 months the labelled add-on, or is another IL-5 biologic the funded option?”
3. United States: “The FDA label is asthma only. Polyps are not an indication here.”
4. Canada / UK / EU / Japan / Australia: “Adult CRSwNP is on this country’s label. Is that my indication, with INCS still on board?”
5. “This is not my rescue inhaler. What is the plan for an acute attack?”
6. “Do I have a worm / helminth risk that should be treated first?”
7. “Who injects — clinic only (US) or trained self-injection (Canada/EU/UK)?”
8. “Do not stop my steroids the day we start. What is the taper plan?”
9. Canada: “This is labelled and marketed, DIN 02568934. SAP is the wrong door. CDA-AMC has not issued a recommendation. What is actually funded in this province? I do not have a listing answer.”
10. UK: “MHRA yes; NICE asthma is suspended; polyps TA1123 is terminated. What is commissioned locally?”
11. Pregnancy, breastfeeding, and (Canada) the 8-month post-dose window.

Canada zoom: authorized and marketed, not funded-by-default

Health Canada has already authorised Exdensur for both asthma (12+) and adult CRSwNP, and the DIN is on the market. That is not a compassionate-access story. The remaining Canadian questions are who pays (unknown) and which indication the specialist is actually writing. Do not call the clinic asking for SAP. Do not assume a provincial drug program has listed it because a DIN exists. CDA-AMC files are open, not decided.

Bottom line

Depemokimab is a twice-yearly add-on IL-5 injection. In the United States it is labelled only for severe eosinophilic asthma in people 12 and older. In Canada, the UK, the EU, Japan, and on the Australian PI it is also labelled for adult severe CRSwNP. China’s NMPA date stays company and is asthma-only on that announcement. NICE is not a yes. Canada’s DIN is authorised and marketed, and not a funding decision. SAP is the wrong door. SWIFT and ANCHOR are completed. Authorized is not funded.

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Primary sources

1. DailyMed EXDENSUR (depemokimab-ulaa), setid 30332b20-2ac0-42ad-a775-d3ca7f5fe29f, BLA 761458 — https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=30332b20-2ac0-42ad-a775-d3ca7f5fe29f
2. GSK USPI/PIL PDF (HCP portal) — https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Exdensur/pdf/EXDENSUR-PI-PIL.PDF
3. GSK US FDA approval PR, 16 Dec 2025 (company; DailyMed used for the legal label) — https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/
4. Health Canada DHPP product page, DIN 02568934, Marketed — https://dhpp.hpfb-dgpsa.ca/dhpp/resource/107120
5. Health Canada Q2 2026 authorizations (Exdensur row 15 Jun 2026) — https://www.canada.ca/en/health-canada/news/2026/07/drugs-and-medical-devices-authorized-april-1-to-june-30-2026.html
6. Canadian Product Monograph (GSK host; Date of Authorization 2026-06-15; Control 290294) — https://ca.gsk.com/media/secnrzhi/exdensur-pm-en.pdf
7. Canadian Product Monograph (HRES) — https://pdf.hres.ca/dpd_pm/00085029.PDF
8. Canadian Patient Medication Information — https://ca.gsk.com/media/bs1jusbr/exdensur_pmi_en.pdf
9. EMA EPAR Exdensur (EC MA 12 Feb 2026) — https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur
10. EPAR Product information (SmPC) — https://www.ema.europa.eu/en/documents/product-information/exdensur-epar-product-information_en.pdf
11. MHRA GOV.UK news, 15 Dec 2025 — https://www.gov.uk/government/news/uk-approves-the-first-twice-yearly-biological-medicine-for-asthma-and-severe-chronic-rhinosinusitis-with-nasal-polyps
12. UK emc SmPC, PL 19494/0329 — https://www.medicines.org.uk/emc/product/101776/smpc
13. PMDA review report P20260116002 — https://www.pmda.go.jp/drugs/2026/P20260116002/340278000_30700AMX00273_A100_1.pdf
14. Japanese GSK approval PR, 22 Dec 2025 (legal-act date cited) — https://jp.gsk.com/ja-jp/news/press-releases/20251222-exdensur/
15. English GSK Japan PR, 6 Jan 2026 (company English) — https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/
16. GSK China NMPA PR, 30 Mar 2026 (company until nmpa.gov.cn) — https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-china-for-the-treatment-of-severe-asthma/
17. Australian PI (Date of first approval 24 Jul 2026) — https://au.gsk.com/media/vusif3jd/exdensur_pi_au.pdf
18. ClinicalTrials.gov SWIFT-1 NCT04719832 — https://clinicaltrials.gov/study/NCT04719832
19. ClinicalTrials.gov SWIFT-2 NCT04718103 — https://clinicaltrials.gov/study/NCT04718103
20. ClinicalTrials.gov ANCHOR-1 NCT05274750 — https://clinicaltrials.gov/study/NCT05274750
21. ClinicalTrials.gov ANCHOR-2 NCT05281523 — https://clinicaltrials.gov/study/NCT05281523
22. ClinicalTrials.gov AGILE NCT05243680 — https://clinicaltrials.gov/study/NCT05243680
23. Jackson DJ, Wechsler ME, et al. Twice-yearly depemokimab in severe asthma with an eosinophilic phenotype. N Engl J Med. 2024;391:2337-2349. DOI 10.1056/NEJMoa2406673 (journal; not the label)
24. Gevaert P, Desrosiers M, Cornet M, et al. Efficacy and safety of twice per year depemokimab in CRSwNP (ANCHOR-1 and ANCHOR-2). Lancet. 2025;405:911-926. DOI 10.1016/S0140-6736(25)00197-7 (journal; not the label)
25. NICE GID-TA11553 / ID6447 (suspended; not a recommendation) — https://www.nice.org.uk/guidance/indevelopment/gid-ta11553
26. NICE TA1123 CRSwNP terminated appraisal — https://www.nice.org.uk/guidance/ta1123
27. CDA-AMC SR0926-000 depemokimab asthma (active review) — https://www.cda-amc.ca/depemokimab
28. CDA-AMC SR0934-000 depemokimab injection CRSwNP (active review) — https://www.cda-amc.ca/depemokimab-injection