Home Heart Disease Treatment CHMP issues positive opinion to expand Jardiance

CHMP issues positive opinion to expand Jardiance

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INGELHEIM, Germany & INDIANAPOLIS--(BUSINESS WIRE)--Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) announced
today that the European Medicines Agency (EMA) Committee for Medicinal
Products for Human Use (CHMP) has issued a positive opinion to update
the labels of Jardiance® (empagliflozin), Synjardy® (empagliflozin
and metformin) and Glyxambi® (empagliflozin and linagliptin)
to include additional important data from the landmark EMPA-REG OUTCOME®
trial on heart failure and kidney endpoints.1,2,3,4

The labels now include additional results from the EMPA-REG OUTCOME®
trial, specifically a relative risk reduction in hospitalisation for
heart failure by 35 percent and a relative risk reduction for new-onset
or worsening of kidney disease by 39 percent with empagliflozin,
compared with placebo, in people with type 2 diabetes and established
cardiovascular disease.1,2,3,4,5

“Heart failure and kidney disease are highly prevalent in people with
type 2 diabetes and are associated with high morbidity and mortality,”
commented Dr Waheed Jamal, Corporate Vice President, Head of
CardioMetabolic Medicine, Boehringer Ingelheim. “Due to the current
unmet medical need to treat these conditions, we are pleased that the
European Medicines Agency has recognised the demonstrated benefits of
empagliflozin to reduce the risks of heart failure and kidney disease in
people with type 2 diabetes and established cardiovascular disease.”

“In the EMPA-REG OUTCOME® trial, empagliflozin demonstrated
superiority in reducing the risk of cardiovascular death in people with
type 2 diabetes and established cardiovascular disease,” said Jeff
Emmick, M.D., Ph.D., Vice President, Product Development, Lilly
Diabetes. “As a result, empagliflozin was the first type 2 diabetes
treatment to have either a cardiovascular indication or data on the
reduction of the risk of cardiovascular death included in the label.”

Based on results from the EMPA-REG OUTCOME® trial, Boehringer
Ingelheim and Eli Lilly and Company are further investigating
empagliflozin in people with heart failure (EMPEROR and EMPERIAL
clinical trials) and chronic kidney disease (EMPA-KIDNEY clinical
trial), both with and without diabetes.6,7,8,9

About EMPA-REG OUTCOME®4,5

EMPA-REG OUTCOME® is a long-term, multinational, randomised,
double-blind, placebo-controlled clinical trial of more than 7,000
people from 42 countries with type 2 diabetes and established
cardiovascular disease.

The study assessed the effect of empagliflozin (10 mg or 25 mg once
daily) added to standard of care compared with placebo added to standard
of care. Standard of care was comprised of glucose-lowering agents and
cardiovascular drugs (including for blood pressure and cholesterol). The
primary endpoint was defined as time to first occurrence of
cardiovascular death, non-fatal heart attack or non-fatal stroke.

The overall safety profile of empagliflozin in the EMPA-REG OUTCOME®
trial was consistent with that of previous trials.

About Heart Failure

Heart failure is a progressive, debilitating and potentially fatal
condition that occurs when the heart cannot pump enough blood around the
body.10 Symptoms of heart failure include difficulty
breathing, swelling, and fatigue amongst others.11 Heart
failure is a prevalent disease; 26 million people around the world have
chronic heart failure.12 There is a high unmet need in the
treatment of heart failure, as approximately 50 percent of people
diagnosed with heart failure will die within five years.13
Additionally, heart failure represents the most common cause of
hospitalisation among individuals aged 65 years and over in the United
States and Europe.12 Heart failure is highly prevalent in
people with diabetes;14 however, approximately half of all
people with heart failure do not have diabetes.12,15

About Chronic Kidney Disease

Chronic kidney disease is defined as a progressive decline of kidney
function over time. About two thirds of chronic kidney disease cases are
attributable to metabolic conditions such as diabetes, obesity and
hypertension.16,17,18

Notably, chronic kidney disease is associated with increased morbidity
and mortality. The majority of deaths among people with chronic kidney
disease occur as a result of cardiovascular complications, often before
reaching end stage kidney disease.19,20,21 Once end stage
kidney disease is reached, affected individuals have to undergo kidney
replacement treatments, such as chronic dialysis or kidney
transplantation.22 Chronic kidney disease is highly prevalent
in various parts of the world, affecting more than 10 percent of the
population.23 Since there is currently no approved treatment
available to specifically reduce kidney disease progression and
cardiovascular death, the overarching unmet medical need for new
treatment options in people with chronic kidney disease is evident.

About Empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once
daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor
and the first type 2 diabetes medicine to include data on the reduction
of the risk of cardiovascular death in the label.24,25,26

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes
and high blood sugar levels leads to excretion of excess sugar in the
urine. In addition, initiation of empagliflozin increases excretion of
salt from the body and reduces the fluid load of the body’s blood vessel
system (i.e. intravascular volume). Empagliflozin induces changes to the
sugar, salt and water metabolism in the body that may contribute to the
reductions in cardiovascular death observed in the EMPA-REG OUTCOME®
trial.

Please click on the following link for ‘Notes to Editors’ and
‘References’: https://www.boehringer-ingelheim.com/press-release/chmp-positive-opinion

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