RIDGEFIELD, Conn.?and?INDIANAPOLIS,?Sept. 9, 2021?/PRNewswire/ --?The?U.S.?Food and Drug Administration?(FDA) granted Breakthrough Therapy designation for Jardiance^??(empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF),?Boehringer Ingelheim?and?Eli Lilly and Company?(NYSE: LLY) announced today. The decision is based on results from the landmark EMPEROR-Preserved phase III trial, in which Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction compared with placebo. The benefit was independent of ejection fraction or diabetes status. Results from EMPEROR-Preserved were presented at the?European Society of Cardiology Congress?2021 on?August 27?and published in?The New England Journal of Medicine. HFpEF accounts for approximately half of the more than 6 million heart failure cases in the?U.S.?No currently approved treatments have been clinically proven to significantly improve outcomes specifically for people with HFpEF. "This Breakthrough Therapy designation underscores the potential of Jardiance to help fill a critical need for a clinically proven treatment for people with this highly prevalent, difficult-to-treat condition," said?Mohamed Eid, M.D., M.P.H., M.H.A., vice president,?Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine,?Boehringer Ingelheim Pharmaceuticals, Inc.?"Following the recent FDA approval of Jardiance for heart failure with reduced ejection fraction, this is another important milestone supporting the potential of?Jardiance as the first therapy clinically proven to improve outcomes across the full heart failure spectrum." According to the FDA, Breakthrough Therapy designation is designed to expedite the development and review of therapies that are intended to treat a serious condition where preliminary clinical evidence indicates potentially substantial improvement over available therapies on a clinically significant endpoint. "Given the scarcity of treatment options for this debilitating condition, the benefits demonstrated in the EMPEROR-Preserved trial constituted a major clinical breakthrough,"?said?Jeff Emmick, M.D., Ph.D., vice president, Product Development,?Lilly. "Together with our?Boehringer Ingelheim?partners, we look forward to working closely with the FDA through this accelerated process to potentially bring Jardiance to adults with heart failure with preserved ejection fraction as soon as possible." The FDA previously granted Fast Track designation for the development of Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure. This designation is for the EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved trials. The EMPEROR-Reduced results formed the basis of the recent FDA approval for heart failure with reduced ejection fraction. Jardiance is not indicated for the treatment of HFpEF. About EMPEROR-Preserved EMPEROR-Preserved?(NCT03057951) was a phase III international, randomized, double?blind trial that enrolled 5,988 adults with and without type 2 diabetes. All participants had heart failure (New York Heart?Association [NYHA] functional class II, III or IV) and preserved ejection fraction (left ventricular ejection fraction > 40%). Participants were randomized to once-daily Jardiance 10 mg (n=2997) or placebo (n=2991), on top of treatment with guideline-directed heart failure therapy. Median follow-up time was 26.2 months. The composite primary endpoint was defined as time to first event of cardiovascular death or hospitalization for heart failure. Prioritizing Cardio-Renal-Metabolic Care Through research and educational initiatives,?Boehringer Ingelheim?and?Lilly?are driven to redefine care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death. The cardiovascular, renal (kidney) and metabolic systems are closely intertwined and share many of the same disease-related pathways. Dysfunction in one system may accelerate the onset of dysfunction in others, resulting in the progression of comorbid diseases such as type 2 diabetes, heart failure and chronic kidney disease. Conversely, improving the health of one system can lead to positive effects across the others and can help reduce the risk for further complications. Understanding their interconnected nature, we are working to advance treatments for people with cardio-renal-metabolic conditions. It is only through a holistic approach to care that we can truly transform outcomes and restore the harmony among these critical systems. What?is?JARDIANCE??(www.jardiance.com) JARDIANCE is?a prescription?medicine used to:

• lower blood sugar along with diet and exercise in adults with type 2 diabetes
• reduce the risk of cardiovascular death in adults with type 2 diabetes who also have known cardiovascular disease
• reduce the risk of cardiovascular death and hospitalization for heart failure (when the heart is weak and cannot pump enough blood to the rest of your body) in adults with heart failure

JARDIANCE?is?not?for?people?with type 1 diabetes. It may increase their risk of diabetic ketoacidosis?(increased ketones?in?the blood or urine). JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work. IMPORTANT?SAFETY?INFORMATION Do?not?take?JARDIANCE?if you?are allergic?to empagliflozin?or?any?of the ingredients?in JARDIANCE. Do?not?take?JARDIANCE?if you are on?dialysis. JARDIANCE?can?cause?serious?side?effects,?including:

• Ketoacidosis (increased ketones in your blood or urine).?Ketoacidosis is a serious condition which needs to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE,?even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE.?Stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms,?and if possible, check for ketones in your urine:
  • • nausea
    • vomiting
    • stomach-area (abdominal) pain
    • tiredness
    • trouble breathing

• Dehydration.?JARDIANCE?can?cause some people to become dehydrated?(the loss?of?body?water?and salt). Dehydration?may?cause you to feel dizzy, faint,?light-headed, or?weak,?especially?when?you stand up. Sudden worsening of kidney function has happened in people who are taking JARDIANCE.

You may?be at?a higher?risk?of?dehydration?if you:

• • take medicines?to lower?your?blood pressure, including?water?pills?(diuretics)
  • are?on?a low?salt?diet
  • have?kidney?problems
  • are?65 years?of?age or?older

Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long.

• Serious urinary tract infections.?Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your healthcare provider if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
• Low?blood?sugar?(hypoglycemia):?If you take JARDIANCE?with another?medicine that?can?cause low?blood sugar, such as?sulfonylurea or?insulin, your?risk?of low?blood sugar?is?higher. The dose of your?sulfonylurea or?insulin?may?need?to be lowered. Symptoms?of?low?blood?sugar?may?include:
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heartbeat
  • sweating
  • shaking or feeling jittery
• Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum).?This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death.?Seek medical attention immediately if you have fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).
• Vaginal?yeast?infection.?Talk?to your?healthcare provider?if you?have vaginal odor,?white or?yellowish vaginal?discharge (discharge may?be lumpy?or?look?like cottage?cheese), and/or?vaginal?itching.
• Yeast?infection?of the penis.?Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis.?Talk?to your healthcare provider?if you have redness, itching?or?swelling?of the?penis,?rash of the penis, foul smelling discharge from?the penis,?and/or?pain?in?the skin?around the?penis.

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

• Allergic (hypersensitivity) reactions.?Symptoms?of?serious?allergic?reactions?to JARDIANCE may?include:
  • swelling of your face, lips, throat, and other areas of your skin
  • difficulty with swallowing or breathing
  • raised, red areas on your skin (hives)

If you have any?of these symptoms,?stop?taking?JARDIANCE?and?contact?your?healthcare provider?or?go to the nearest?emergency?room?right?away.

The?most?common?side?effects?of?JARDIANCE?include?urinary?tract?infections?and?yeast?infections?in females. These?are?not?all?the?possible?side?effects?of?JARDIANCE.?For?more?information,?ask?your?healthcare provider?or?pharmacist. Before taking JARDIANCE, tell?your?healthcare provider?about all of your medical conditions, including if?you:

• have kidney?problems
• have liver?problems
• have a history of infection of the vagina or penis
• have a history?of urinary?tract?infections?or?problems?with urination
• are going to have surgery. Your healthcare provider may stop your JARDIANCE before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking JARDIANCE and when to start it again
• are eating less or there is a change in your diet
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
• drink alcohol very often, or drink a lot of alcohol in the short term ("binge" drinking)
• have type 1 diabetes. JARDIANCE should not be used to treat people with type 1 diabetes
• are pregnant?or?plan?to become pregnant. JARDIANCE may harm?your?unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with JARDIANCE
• are breastfeeding?or?are planning to breastfeed. JARDIANCE may pass into your?breast?milk and may harm your baby. Do not breastfeed while taking JARDIANCE

Tell?your?healthcare provider?about?all?the medicines?you take,?including?prescription?and over-the-counter medicines, vitamins, and?herbal supplements.?Especially?tell your?healthcare provider?if?you take?water?pills (diuretics)?or?medicines?that?can?lower?your?blood?sugar,?such as?insulin. You are encouraged?to?report?negative side effects?of?prescription?drugs to?the?FDA.?Visit?www.fda.gov/medwatch?or?call 1-800-FDA-1088. For?more?information,?please?see?Prescribing?Information?and?Medication Guide. CL-JAR-100093?08.18.2021 Boehringer Ingelheim?and?Eli Lilly and Company In?January 2011,?Boehringer Ingelheim?and?Eli Lilly and Company?announced an alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the alliance. The alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of Jardiance on people living with heart failure or chronic kidney disease. About?Boehringer Ingelheim Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885,?Boehringer Ingelheim?is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good. As a world-leading, research-driven pharmaceutical company, with around 52,000 employees, we create value through innovation daily for our three business areas: Human Pharma,?Animal Health, and Biopharmaceutical Contract Manufacturing. In 2020,?Boehringer Ingelheim?achieved net sales of around?22.33 billion USD?(19.57 billion EUR). Our significant investment of over?4.2 billion USD?(3.7 billion EUR) in 2020 (18.9% of net sales) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life. We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come. Boehringer Ingelheim Pharmaceuticals, Inc., based in?Ridgefield, CT, is the largest?U.S.?subsidiary of?Boehringer Ingelheim Corporation?and is part of the?Boehringer Ingelheim?group of companies. In addition, there are?Boehringer Ingelheim Animal Health?in?Duluth, GA?and?Boehringer Ingelheim Fremont, Inc.?in?Fremont, CA. Boehringer Ingelheim?is committed to improving lives and strengthening our communities. Please visit?www.boehringer-ingelheim.us/csr?to learn more about Corporate Social Responsibility initiatives. For more information, please visit?www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. About?Lilly?Diabetes Lilly?has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions?from medicines and technologies to support programs and more. For the latest updates, visit?http://www.lillydiabetes.com/?or follow us on Twitter:?@LillyDiabetes?and Facebook:?LillyDiabetesUS. About Eli?Lilly?and Company? Lilly?is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe,?Lilly?employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about?Lilly, please visit us at?lilly.com?and?lilly.com/newsroom. This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects?Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from?Lilly's expectations, please see?Lilly's most recent Forms 10-K and 10-Q filed with the?U.S. Securities and Exchange Commission.?Lilly?undertakes no duty to update forward-looking statements. Jardiance? and EMPA-REG OUTCOME? are?registered trademarks of?Boehringer Ingelheim. P-LLY MPR-US-101853 CONTACTS: Jennifer Forsyth Director, Public Relations Boehringer Ingelheim Pharmaceuticals, Inc. Email:?jennifer.forsyth@boehringer-ingelheim.com Phone: (203) 791-5889 Anna Bergmann Global Business Communications Eli Lilly and Company Email:?anna.bergmann@lilly.com Phone: (317) 864-3143    

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