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Medicines in Development for Diabetes

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Medicines in Development for Diabetes 2014 MEDICINES IN DEVELOPMENT REPORT Diabetes PRESENTED BY AMERICA’S BIOPHARMACEUTICAL RESEARCH COMPANIES Biopharmaceutical Research Companies Are Developing 180 Medicines to Treat Diabetes and Related Conditions Nearly 26 million Americans are affected options for patients battling diabetes by diabetes—including 7 million people and diabetes-related conditions. who are unaware they have the disease. Medicines in Development One of the top 10 causes of death in the According to the Centers for Disease For Diabetes United States, diabetes has far-reaching Control and Prevention (CDC), death implications for patients and their fami- rates for people with diabetes fell sub- Application lies and our health care system. stantially—up to 40 percent—between Submitted 1997 and 2006. CDC links this decrease Phase III While healthy eating and exercise can to improved cardiovascular medical Phase II help prevent and manage type 2 diabe- treatment, better management of diabe- tes, medicines play a key role in helping tes, and some healthy lifestyle changes. Phase I reduce the risk of and treat the disease. For example, one medicine was found in Unfortunately, while the death rates due studies to lower the risk by 31 percent. to diabetes are declining, the rate of new cases has been rising. The number of 100 And in recent years, eight new classes of type 2 diabetes medicines have been ap- Americans diagnosed with diabetes has proved by the Food and Drug Administra- more than tripled since 1980, according tion (FDA), giving patients and health care to the CDC. Lifestyle choices can affect providers powerful new options to treat this increase. The CDC-led National this chronic and devastating condition. Diabetes Prevention Program found that To build on progress to date and help Contents further meet the challenges posed by Recent Diabetes Medicine diabetes, America’s biopharmaceutical 52 Approvals .......................................2 research companies are developing 180 Diabetes Medicines in the Pipeline ......2 new medicines for type 1 and type 2 Early Diabetes Breakthroughs ............3 diabetes and diabetes-related conditions, Diabetes Medications— such as chronic kidney failure due to Improving Adherence ...................... 4 30 diabetes and painful diabetic neuropathy. Treatment Intensifi cation/ Clinical Inertia .................................5 Additionally, there are 200 active dia- Facts About Diabetes in the 16 betes clinical trials in the United States, United States ................................. 6 including 140 that have not yet started Medicines in Development ................7 recruiting patients or are just now seek- Glossary ....................................... 21 ing volunteers to participate and another Drug Development/ Approval Process ...........................23 60 that are active, but not recruiting new patients. In addition to the critical ype 1 ype 2 T T Diabetes Diabetes Diabetes onditions role these trials play in the development Unspecified C and testing of new treatments, they rep- resent potentially valuable therapeutic Diabetes-Related Key Issues weight loss and increased physical activity in people at high risk for diabetes reduced the development of type 2 diabetes MEDICINESMEDICINES IN DEVELOPMENTDEVELOPMENT FORFOR DIABETES by 58 percent in a three-year period. BIOPHARMACEUTICAL RESEARCH According to the American Diabetes Association, most Ameri- COMPANIES ARE DEVELOPING cans with diabetes have type 2, in which relative insulin defi - ciency combines with the body failing to properly use insulin. Between 5 percent and 10 percent of Americans with diabetes 180 MEDICINES have type 1, in which the body fails to produce insulin. TO TREAT The medicines in the pipeline today offer hope of reducing TYPE 1 & TYPE 2 DIABETES the human toll and economic costs of diabetes. Examples of some medicines now being tested include: INCLUDING – AND – • A medicine that improves glucose-dependent insulin FOR DIABETES FOR DIABETES-RELATED secretion. 128 52 CONDITIONS • A medicine designed to inhibit an enzyme linked to diabetic neuropathy. • A treatment designed to stimulate and enhance the regeneration of insulin-producing cells. Source: PhRMA, 2014 Medicines in Development for Diabetes While diabetes remains a challenging illness, America’s biophar- maceutical research companies are continuing their efforts to develop novel and more effective therapies to treat the disease and improve the quality of life for diabetes patients. Diabetes Medicines in the Pipeline Recent Diabetes Medicine America’s biopharmaceutical research companies continue to explore many different approaches to battle diabetes and Approvals related-conditions. Some potential innovations from the 180 New medicines approved by the FDA in the last year repre- medicines in development today, include: sent exciting steps forward in efforts to better treat diabetes. Stimulating the Formation of Insulin Producing Cells— These include: A potential fi rst-in-class treatment for type 1 diabetes is • Nesina ® (alogliptin) is a new DPP-4 inhibitor designed to designed to stimulate and enhance the regeneration of slow the inactivation of incretin hormones GLP-1 and GIP, insulin-producing cells (islets). The treatment is a human resulting in more active incretins enabling the pancreas to peptide consisting of the bioactive part of a gene respon- secrete insulin and better managing blood glucose levels. sible for regenerating pancreatic islets. In diabetes, there are often too few insulin-producing islets to keep up with • Invokana® (canaglifl ozin) is the fi rst sodium-glucose co- the demand for insulin. transporter 2 (SGLT2) inhibitor approved for patients with type 2 diabetes. SGLT2 inhibitors work in conjunction with Next-Generation Oral Treatment—A medicine in develop- the kidneys and the natural urination process to remove ment for the treatment of type 2 diabetes is part of the excess blood glucose from the body. DPP-4 inhibitor class, but chemically distinct from other approved medicines in this class. DPP-4 inhibitors work by • Duetact® (pioglitazone/glimepiride) combines two previ- stimulating the production of insulin and producing less glu- ously approved type 2 diabetes medicines with comple- cose. In clinical trials, the medicine was able to inhibit more mentary actions in a single tablet. One medicine targets than 80 percent of its target enzyme for seven days, making insulin resistance while the other increases the amount of it potentially a once-weekly treatment versus daily. insulin produced by the pancreas. Once-Weekly Treatment—A medicine in development is in • Farxiga ™ (dapaglifl ozin) is a new SGLT2 inhibitor approved the same class of drugs as some other approved medicines to improve glycemic control in adults with type 2 diabetes. for type 2 diabetes, but with a longer therapeutic life that 2 Medicines in Development Diabetes 2014 Key Issues MILLIONSMILLIONS OFOF AMERICANSAMERICANS AFFECTEDAFFECTED BY DIABETES TREATREATMENT ISIS IMPORTIMPORTANT TOTO CONTROLCONTROL DIABETEDIABETES 7 MILLION EACH DAY MORE THAN 26 MILLION 19 MILLION 7 MILLION 5,000 AMERICANS are are AMERICANS AMERICAN ADULTS are affected by DIAGNOSED UNDIAGNOSED are DIABETES UNDIAGNOSED are diagnosed with DIABETES 16 MILLION 3 MILLION are are DIAGNOSED TREATED but NOT TREATED 19 MILLION 79 MILLION AMERICANS AMERICAN ADULTS 8 MILLION have been have 8 MILLION have not successfully controlled DIABETES diagnosed with PREDIABETES controlled DIABETES WITH TREATMENT DIABETES WITH TREATMENT DIABETES AFFECTS NEARLY 8 MILLION 18 MILLION have have ABOUT ONE-QUARTER CONTROLLED UNCONTROLLED 26 MILLION DIABETES DIABETES AMERICANS } ARE UNAWARE THEY HAVE THE DISEASE Source: Centers for Disease Control and Prevention (CDC) Source: Centers for Disease Control and Prevention (CDC), National Health and Nutrition Examination Survey (NHANES) may make it suitable for once-weekly dosing. The medicine is —a chronic progressive kidney disease that is the leading a human glucagon-like peptide (GLP-1) analogue that lowers cause of end-stage renal disease (ESRD) or kidney failure. blood glucose and reduces body weight. From 1990 to 2006, ESRD due to diabetic nephropathy increased 2.5 times. The medicine has demonstrated the Facilitating Glucose Regulation—A potential medicine in potential to protect kidney function and slow disease pro- development for type 2 diabetes is a gut sensory modulator gression when added to existing therapy. (GSM) delivered directly to the stomach where it intensifi es the body’s natural food-driven signals that facilitate glucose regulation. The medicine, a delayed-release formulation of Early Diabetes Breakthroughs metformin (a medicine used to treat diabetes alone or in com- bination with other medicines), targets the lower gut to avoid Basic research is important to fi nding new treatments and systemic absorption in the bloodstream, making it potentially possibly a cure for diabetes. Recent research discoveries offer useful to diabetes patients with renal impairment who are hope that they can one day lead to new effective treatments. unable to use metformin due to the risk of building metfor- Some of the new discoveries include: min up in the blood (lactic acidosis). • Researchers at the Harvard Stem Cell Institute discovered a Painful Nerve Damage—Nerve damage is a common symp- hormone that can stimulate production of insulin-secreting tom of diabetes. About half of all people with diabetes have pancreatic beta cells up to 30 times the normal rate in mice. some
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