Pramlintide 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
This is adjunctive diabetes evidence
The 2005 medical review concerns Symlin used with insulin in type 1 or type 2 diabetes. FDA distinguishes a pharmacological amylin analogue from physiological replacement therapy; these findings should not be transferred to every amylin-based investigational drug. FDA PDF pp. 5, 10 ↗
More findings, study links and document coverage
A modest average glycemic effect
For type 2 diabetes, the reviewer cites an approximately 0.4 percentage-point HbA1c difference versus placebo at six months in study 137-111. This is distinct from a change from baseline and from the weight outcomes reported elsewhere in the program. FDA PDF pp. 9 ↗
Severe hypoglycemia shaped the approval review
Severe hypoglycemia with concomitant insulin was the central recurring safety concern. The reviewer’s approval recommendation included a boxed warning and risk-management measures; average glycemic improvement alone did not settle the benefit-risk assessment. FDA PDF pp. 8, 9, 10 ↗
Open-label comparisons cannot erase the blinded-trial signal
The resubmission used open-label clinical-practice studies and comparisons with earlier blinded trials. Different insulin-use patterns and study conditions complicate attributing lower observed hypoglycemia solely to pramlintide. FDA PDF pp. 8, 17 ↗
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.
Selected English EMA PDFs from the retained September 15, 2026 title-matched document feed, plus independently retrieved FDA approval-package documents where listed. Candidate entries are not verified product/application matches. This is a bounded inventory, not a complete FDA, national or worldwide source search. 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.
Symlin: FDA 2005 selected approval-package clinical review ↗
Selected sections reviewed · fda-symlin-medical-2005 · Document/feed date: 2005-02-18
Independently retrieved FDA approval-package PDF. The displayed date belongs to the selected review, not the entire compilation or a current label.
Verified: Symlin · NDA 021332 · Document dated 2005-02-18. Identity checked on PDF pp. 1, 5.
Identity and selected clinical design, efficacy, safety and benefit-risk sections only. One-based PDF file pages; unlisted pages have not been appraised. The date identifies the selected review within any compiled approval package.
Retrieved 2026-09-19. Read PDF pages: 1, 2, 4, 5, 6, 8, 9, 10, 17 of 304. SHA-256:
58967db5da7311cdfbf249a39b86c61b48babcb5d2a8e2539246dfb3ca5c577f.
Remaining work
- Read the remaining original trial-level efficacy and safety tables and subsequent label changes.
- Separate controlled trials, open-label extensions and mechanistic studies when completing the literature review.