🧬 Endocrinology Update: New denosumab versions, Tzield in China and More
In this week’s update, we cover key developments shaking up the endocrinology landscape. From the FDA’s approval of denosumab biosimilars like Bildyos and Bilprevda to China’s groundbreaking approval of Tzield for delaying stage 3 type 1 diabetes, we bring you the latest news. Learn about the halt of two Phase 2 trials of Eli Lilly’s naperiglipron, Medtronic’s MiniMed 780G expansion to type 2 diabetes, and more.
đź“Ś In This Episode:
đź’Š Renata launches fludrocortisone 0.1 mg tablets in the UK [1]
https://www.tbsnews.net/economy/corporates/renata-launches-fludrocortisone-tablets-uk-1226886
Claim: Renata PLC launched fludrocortisone 0.1 mg tablets in the UK for Addison’s disease and salt-losing adrenogenital syndrome.
Context: Supplied from an MHRA-approved facility; source notes stability ≤25 °C vs innovator refrigeration (2–8 °C).
Where/When: UK, 02 Sep 2025.
Implication: Introduces competition that may affect pricing and formulary access.
🧪 Lilly ends two of three Phase 2 naperiglipron trials [2]
https://www.medpagetoday.com/endocrinology/generalendocrinology/117266
Claim: MedPage Today’s roundup reports Eli Lilly terminated two of three Phase 2 studies of oral GLP-1 naperiglipron (details not specified).
Context: Item listed alongside device and bone-health updates.
Where/When: 02 Sep 2025.
Implication: Signals pipeline investment and modality expansion.
🦴 FDA approves denosumab biosimilars Bildyos & Bilprevda [3]
https://www.pharmabiz.com/NewsDetails.aspx?aid=181025&sid=2
Claim: FDA approved Henlius/Organon’s Bildyos (denosumab-nxxp) and Bilprevda (denosumab-nxxp) for all Prolia/Xgeva reference indications.
Context: Label cautions severe hypocalcemia (esp. CKD/CKD-MBD) and ONJ; approvals supported by analytical, PK, and comparative clinical data.
Where/When: US, 03 Sep 2025.
Implication: Introduces competition that may affect pricing and formulary access.
🤰 Early OGTT predicts gestational diabetes and insulin need [4]
https://www.meduniwien.ac.at/web/en/ueber-uns/news/2025/news-in-september-2025/reliably-predicting-the-risk-of-gestational-diabetes/
Claim: Early 75 g OGTT glucose values (fasting/60/120 min) predicted later GDM and need for insulin therapy.
Context: Prospective multicentre cohort (n=657; Austria/Germany/Switzerland); 12.6% developed GDM; biomarkers (insulin, triglycerides, adiponectin) were less predictive.
Where/When: 03 Sep 2025.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🫶 Caregiver-involved diabetes education improves self-management [5]
https://www.healio.com/news/endocrinology/20250903/caregiver-involvement-in-diabetes-education-improves-selfmanagement-skills
Claim: A 4-week family-centered DSMES program improved self-management and self-efficacy; reduced diabetes distress at 12 weeks.
Context: Pilot (n=49 enrolled); small mean HbA1c change overall; significant drop only when baseline HbA1c >8% (presentation data).
Where/When: US, 03 Sep 2025.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🤖 MiniMed 780G expands to insulin-requiring type 2 diabetes (investor note) [6]
https://simplywall.st/stocks/us/healthcare/nyse-mdt/medtronic/news/medtronic-mdt-expands-minimed-system-to-type-2-diabetes-with
Claim: Investor note highlights FDA milestones expanding MiniMed 780G use to adults with insulin-requiring type 2 diabetes.
Context: Market-oriented analysis; labeling specifics not detailed here.
Where/When: US, 03 Sep 2025.
Implication: May influence prescriber choice and payer reviews pending full data.
⚠️ FDA targets unapproved animal-derived thyroid medications [7]
FDA Cracks Down on Unapproved Animal-Derived Thyroid Medications
Claim: FDA warned that desiccated thyroid extracts are unapproved, with potency variability and impurity risks; intends enforcement and urges transitions to approved meds.
Context: Notes products are ineligible for compounding; adverse event reports cited.
Where/When: US, 04 Sep 2025.
Implication: May influence prescriber choice and payer reviews pending full data.
đź“‘ ATA issues 2025 guidelines for differentiated thyroid cancer [8]
https://southfloridahospitalnews.com/smh-specialist-among-leading-physician-researchers-issuing-latest-guidance-for-thyroid-cancer-care/
Claim: American Thyroid Association released updated adult DTC management guidelines (published in Thyroid).
Context: Covers diagnosis, staging, initial treatment, response assessment, monitoring, survivorship; granular changes not detailed in this source.
Where/When: US, 05 Sep 2025.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 AbbVie tests Armour Thyroid vs levothyroxine (Phase 2/3) [9]
https://www.tipranks.com/news/company-announcements/abbvies-hypothyroidism-study-a-potential-game-changer-in-thyroid-treatment
Claim: Ongoing randomized, triple-masked Phase 2/3 compares Armour Thyroid with levothyroxine in adults with primary hypothyroidism (dose-conversion focus).
Context: Study start 27 Mar 2024; latest update 13 Aug 2025; completion dates not stated.
Where/When: 07 Sep 2025.
Implication: May influence prescriber choice and payer reviews pending full data.
🇨🇳 Tzield approved in China to delay stage 3 T1D onset [10]
https://www.chinadaily.com.cn/a/202509/08/WS68be6ed0a3108622abc9f705.html
Claim: Sanofi says NMPA approved Tzield for patients ≥8 years with stage 2 type 1 diabetes to delay progression to stage 3.
Context: Company cites nearly 3-year delay; article notes pediatric burden and national T1D prevalence.
Where/When: China, 08 Sep 2025.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
US denosumab biosimilars could reduce costs and expand access across osteoporosis and oncology support. [3]
First-trimester OGTT risk stratification may shift GDM screening earlier in pregnancy. [4]
FDA’s stance on desiccated thyroid may consolidate hypothyroidism care toward approved synthetic options. [7]
Family-centered DSMES can improve self-management metrics, though larger trials are needed. [5]
China’s Tzield approval broadens disease-modifying prevention access for type 1 diabetes. [10]
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FAQ
What do Bildyos and Bilprevda cover?
All Prolia/Xgeva reference indications, including high-risk osteoporosis, GIOP, bone loss with ADT/AI therapy, SRE prevention in myeloma/solid-tumor bone metastases, giant cell tumor of bone, and refractory hypercalcemia of malignancy. [3]
How predictive is early OGTT for GDM?
In a prospective multicentre cohort (n=657), early fasting/60/120-min glucose values predicted later GDM and insulin need; additional biomarkers were less informative. Observational design applies. [4]
What exactly did FDA say about animal-derived thyroid products?
They’re unapproved, can have inconsistent potency and impurities; FDA intends enforcement and advises transitioning patients to approved levothyroxine/liothyronine. [7]
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Did MiniMed 780G expand to type 2 diabetes?
An investor note cites FDA milestones expanding 780G to insulin-requiring adults with T2D; specific labeling details aren’t provided in this source. [6][2]
What is AbbVie studying in hypothyroidism?
A randomized, triple-masked Phase 2/3 comparing Armour Thyroid with levothyroxine, focusing on dose conversion, efficacy, and safety; timelines not finalized. [9]
Where was Tzield newly approved and for whom?
In China, for people aged ≥8 years with stage 2 type 1 diabetes to delay progression to stage 3, per Sanofi. [10]
Entities / Keywords
Renata PLC; fludrocortisone 0.1 mg (UK) • Eli Lilly; naperiglipron (oral GLP-1) • Henlius; Organon; Bildyos; Bilprevda; denosumab biosimilars • MedUni Vienna; early 75 g OGTT; GDM • DSMES “Live in Control”; ADCES25 • Medtronic; MiniMed 780G; insulin-requiring T2D • FDA; desiccated thyroid extract (DTE) • American Thyroid Association; differentiated thyroid cancer guidelines • AbbVie; Armour Thyroid; levothyroxine • Sanofi; Tzield; stage 2→3 type 1 diabetes.
References
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https://www.tbsnews.net/economy/corporates/renata-launches-fludrocortisone-tablets-uk-1226886
https://www.medpagetoday.com/endocrinology/generalendocrinology/117266
https://www.pharmabiz.com/NewsDetails.aspx?aid=181025&sid=2
https://www.meduniwien.ac.at/web/en/ueber-uns/news/2025/news-in-september-2025/reliably-predicting-the-risk-of-gestational-diabetes/
https://www.healio.com/news/endocrinology/20250903/caregiver-involvement-in-diabetes-education-improves-selfmanagement-skills
https://simplywall.st/stocks/us/healthcare/nyse-mdt/medtronic/news/medtronic-mdt-expands-minimed-system-to-type-2-diabetes-with
https://www.clinicaladvisor.com/news/fda-cracks-down-on-unapproved-animal-derived-thyroid-medications/https://southfloridahospitalnews.com/smh-specialist-among-leading-physician-researchers-issuing-latest-guidance-for-thyroid-cancer-care/
https://www.tipranks.com/news/company-announcements/abbvies-hypothyroidism-study-a-potential-game-changer-in-thyroid-treatment
https://www.chinadaily.com.cn/a/202509/08/WS68be6ed0a3108622abc9f705.html
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