Boehringer Ingelheim — Synjardy EMA EPAR variation assessment report (EMEA/H/C/003770, 2015)

Boehringer Ingelheim · 2015 · EMA EPAR variation assessment report

Report summary

Boehringer Ingelheim sought to extend Synjardy's (empagliflozin/metformin) indication to children aged 10 and above with type 2 diabetes. The EMA's CHMP recommended approval based on the DINAMO study (1218.91). This 26-week, double-blind, placebo-controlled trial, with a 52-week extension, evaluated empagliflozin and linagliptin, primarily on a metformin background. Empagliflozin significantly reduced HbA1c compared to placebo at 26 weeks, while linagliptin did not. Safety profiles were generally comparable to placebo, with increased hypoglycemia in the empagliflozin group. The benefit-risk balance for this pediatric population was considered positive.

Key findings — cited to the page

Mean total daily dose of metformin at baseline	1661.5 mg	· p.23
PECsurface water for already approved metformin indication	10.0 µg/L	Metformin · p.10
Refined PECsurface water for empagliflozin	0.00034 µg/L	Empagliflozin · EU · p.10
Empagliflozin IC50	1.3 nmol	Empagliflozin · p.8
Prevalence of orphan-like paediatric indication	0.6 – 2.7 / 100,000	· p.10
Refined PECsurface water for metformin	0.03 µg/L	Metformin · p.10
Application submission date	13 February 2024	Synjardy · p.6
Variation type	C.I.6.a - Change(s) to therapeutic indication(s) - Addition of a new therapeutic indication or modification of an approved one	Synjardy · p.6
Variation type	Type II	Synjardy · p.6
Paediatric waiver decision number	P/271/2011	· p.6
Recommendation for approval	recommended for approval	Synjardy · p.7
PECsurface water for empagliflozin (all indications)	0.125 µg/L	Empagliflozin · p.12

Source: Boehringer Ingelheim ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →