CHMP Adopts Positive Opinion for Jardiance (Empagliflozin) to Treat All Chronic Heart Failure Patients Regardless of Ejection Fraction
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.
Today, 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 on the SGLT2 inhibitor Jardiance (empagliflozin) supporting its use for the treatment of symptomatic chronic heart failure patients. Previously, empagliflozin had already been approved for the treatment of heart failure with reduced ejection fraction (HFrEF). The press release noted that if approved, empagliflozin would cover all types of heart failure patients regardless of their ejection fraction.
Empagliflozin is a once-daily oral, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. In patients with type 2 diabetes with higher blood glucose levels, inhibiting SGLT2 prevents the kidneys from reabsorbing sugar, allowing more sugar to be excreted in the urine. Additionally, empagliflozin reduces the reabsorption of salt, thereby increasing salt excretion and reducing fluid load in the body’s vascular system. The metabolic changes in sugar, salt, and water induced by empagliflozin may contribute to reducing cardiovascular death. It received FDA approval in August last year to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction.
The positive opinion of the CHMP is based on the results of the Phase 3 clinical trial EMPEROR-Preserved. The trial results showed that, compared with placebo, empagliflozin reduced the relative risk of cardiovascular death or hospitalization for heart failure by 21% in adult patients with heart failure with preserved ejection fraction (HFpEF). This benefit was independent of the patient's ejection fraction and whether they had diabetes.
References:
[1] CHMP issues positive opinion to expand Jardiance (empagliflozin) indication based on unprecedented benefit in adult heart failure patients with preserved ejection fraction. Retrieved January 28, 2022, from https://www.businesswire.com/news/home/20220127005861/en
(Original text has been abridged)
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