Boehringer Ingelheim and Eli Lilly Announce Positive CHMP Opinion Recommending Jardiance® (Empagliflozin) for Treatment of Chronic Kidney Disease in Adults in the EU
Boehringer Ingelheim
Developer of Innovative Drugs and Therapies
Eli Lilly
Global Pharmaceutical R&D and Production Company
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
Recently, Boehringer Ingelheim and Eli Lilly and Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending Jardiance® (empagliflozin) for the treatment of chronic kidney disease (CKD) in adults. Empagliflozin is currently used to treat adult heart failure and type 2 diabetes. Once approved, the indications for empagliflozin in the EU will include adult CKD, paving the way for management strategies addressing increased patient risks due to cardio-renal-metabolic diseases.
It is reported that the EMPA-KIDNEY III Phase trial includes 6,609 adult patients with chronic kidney disease of varying severity, extensive underlying causes, and comorbidities, making EMPA-KIDNEY the largest and most comprehensive SGLT2 inhibitor trial for chronic kidney disease to date. Empagliflozin demonstrated significant renal and cardiovascular benefits in adult patients with chronic kidney disease, reducing the relative risk of kidney disease progression or cardiovascular death by 28% compared to placebo.
Editor: Muyan
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