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BRIEF-Novo Nordisk gets positive opinion for label update in EU for Tresiba
September 29, 2017 / 2:10 PM / in 20 days

BRIEF-Novo Nordisk gets positive opinion for label update in EU for Tresiba

Sept 29 (Reuters) - NOVO NORDISK SAYS

* THE COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE UNDER THE EUROPEAN MEDICINES AGENCY (EMA) HAS ENDORSED AN UPDATE OF THE EU LABEL WITH IMMEDIATE EFFECT FOR TRESIBA TO INCLUDE RESULTS FROM THE DEVOTE TRIAL ON SEVERE HYPOGLYCAEMIA

* DEVOTE IS A RANDOMISED, MULTINATIONAL AND DOUBLE-BLINDED TRIAL CONDUCTED TO CONFIRM THE CARDIOVASCULAR SAFETY OF TRESIBA COMPARED TO INSULIN GLARGINE U100 WHEN ADDED TO STANDARD OF CARE, IN PEOPLE WITH TYPE 2 DIABETES

* IN THE TRIAL, THE PRIMARY ENDPOINT WAS ACHIEVED BY DEMONSTRATING NON-INFERIORITY OF MAJOR ADVERSE CARDIOVASCULAR EVENTS WITH TRESIBA COMPARED TO INSULIN GLARGINE U100 Further company coverage: (Copenhagen newsroom)

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