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Eli Lilly's Trulicity (dulaglutide) Receives CHMP Recommendation for Label Update to Include Results from REWIND Study

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Eli Lilly's Trulicity (dulaglutide) Receives CHMP Recommendation for Label Update to Include Results from REWIND Study

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  • The EMA’s CHMP recommends an update to the Trulicity label and indication statement to include results from REWIND CV outcome study- demonstrating 12% reduction in MACE- reflecting both glycemic control and impact on CV events as fundamental considerations in patients with T2D
  • The REWIND study involves assessing of Trulicity (1.5mg- qw) + SOC vs PBO + SOC in 9-901 patients on CV risk with T2D from 24 countries- resulting in CV disease only in 31% patients while all had CV risk factor
  • Trulicity is the glucagon-like peptide-1 receptor agonist (GLP-1 RA)- indicated to improve blood sugar (glucose) in adults with T2D (Mellitus) in adjunct to diet and exercise and is under EC’s review for approval in the EU

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Ref: Eli Lilly | Image: Eli Lilly


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