[메디파나뉴스] CV and kidney of European CHMP "Zadien" benefit from "positive opinion"



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Boehringer Ingelheim and Eli Lilly announced on June 28 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) On the basis of additional data on heart failure and the kidney of REG OUTCOME, it is known that the combination of "Zodiac (empagliprozin)", "Sinzadi & # 39; (name of the ingredient: empagoliprojin + metformin,) and `Glychemi (Ingredients: Empagirifrojin + Lynagliptin) 'in Europe

As a result, the approval of Zadignan, Sinjadi (Korean name: Zadine duo) and Glycambi in Europe showed that empolgloflozin in patients with type 2 diabetes diagnosed with cardiovascular disease RESULTS REG, which reduces the risk of hospitalization by 35%, reduces the risk of new disease renal or exacerbation of kidney disease by 39%.

"Heart failure and kidney disease are badociated with high morbidity and mortality as well as a high incidence in patients with type 2 diabetes," said Boheed Jamal, vice- President of Boehringer Ingelheim and Head of the Cardiovascular Disorders Division. Considering the unmet medical needs that still exist in the treatment of these diseases, the European Medicines Agency will benefit from the use of empagoliproline to reduce the risk of heart failure and disease kidney in patients with type 2 diabetes diagnosed with cardiovascular disease C is very encouraging to recognize it, "he said.

Dr. Jeff Emmick, vice president of diabetes division of Lily, said: "Empagriplogin has been shown to be effective in patients with type 2 diabetes who have been diagnosed with cardiovascular disease through EMPA-REG OUTCOME® clinical studies." Empazyriflozine has become the first treatment of type 2 diabetes to include a study of cardiovascular indications or a reduction in the risk of cardiovascular mortality in product licensing, "he said.

On the other hand, Boehringer Ingelheim and Eli Lilly have conducted clinical trials on EMPA-REG OUTCOME to determine whether patients with heart failure (EMPEROR and EMPERIAL clinical studies) and patients with chronic renal failure (EMPA-KIDNEY

<© 2018 메디파나뉴스, 무단 전재 및 배포금지> 'The Korean Pharmaceutical Information Center & # 39; Medifana News

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