Glucagon official document review · version 1
This page preserves this version's findings, scope and source pins. Open the current profile →
Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
The pivotal question was recovery from hypoglycemia
EMA’s Ogluo review describes controlled studies of glucagon in people with diabetes. The pivotal adult endpoint was blood-glucose recovery within 30 minutes; the pediatric study was open-label. EMA PDF pp. 106, 107 ↗
More findings, study links and document coverage
Noninferiority did not mean identical recovery speed
The adult study met its noninferiority criterion, but EMA reported slower glucose recovery after administration than the reference product. Preparation time and the time measured after injection are distinct comparisons. EMA PDF pp. 107, 108 ↗
Usability studies answer a different question
Human-factors studies tested successful device use, including simulated emergencies. Their results support a usability assessment; they are not the same as observing clinical outcomes during spontaneous severe hypoglycemia. EMA PDF pp. 107, 108, 111 ↗
The formulation and population define the scope
This assessment concerns the ready-to-use Ogluo formulation and its severe-hypoglycemia indication. A real-world actual-use study was planned; that plan is not a completed result in this document. EMA PDF pp. 108, 112 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Document coverage
Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.
One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗
Inspect documents, application identities and source pins
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Ogluo : EPAR - Public assessment report ↗
Selected sections reviewed · ema-50305 · Document/feed date: 2021-02-26
Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.
Verified: Ogluo · EMEA/H/C/005391 · Document dated 2020-12-10. Identity checked on PDF pp. 1.
Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.
Retrieved 2026-09-19. Read PDF pages: 1, 106, 107, 108, 111, 112 of 114. SHA-256:
7cd33c516e2e3f15b9de4e3d25054354e74e316483d85afa02f37ddbe1463199.Feed-listed application (not a verified association): EMEA/H/C/005391.
Remaining work
- Review actual-use follow-up and separately assess other glucagon delivery systems.
- Reconcile pediatric age groups, study timing and real emergency outcomes with current formulation-specific labels.