RARITAN, N.J., Dec. 12, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced it has received from the U.S. Food and Drug Administration (FDA) a complete response letter regarding its New Drug Application (NDA) for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes.
The complete response letter related to the NDA requested additional information to support the comparability of the twice-daily dosing regimen of canagliflozin -- as part of the canagliflozin and metformin FDC -- and the once-daily dosing of canagliflozin as a single agent. Janssen believes it can supply this information based on available clinical data from the comprehensive Phase 3 clinical development program for canagliflozin.
"We continue to have productive discussions with the FDA and will work closely with the agency to advance this application," said Norman Rosenthal, MD, FACE, FACP, canagliflozin compound development team leader, Janssen Research & Development, LLC. "We look forward to addressing questions from the FDA as soon as possible and remain committed to providing therapeutic options that meet the needs of the type 2 diabetes community."
Canagliflozin is an oral medication that selectively inhibits sodium glucose co-transporter 2 (SGLT2), a carrier responsible for the reabsorption of glucose by the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with type 2 diabetes. Metformin is a first-line oral medication that can be used alone or with other medications, including insulin, to treat type 2 diabetes. Metformin lowers blood glucose levels by decreasing the amount of glucose made by the liver.
If approved, the canagliflozin and metformin fixed-dose combination could provide convenience for patients who may benefit from the two diabetes medications in one tablet. Janssen announced the submission of the canagliflozin/metformin fixed-dose combination therapy NDA on December 12, 2012.
In March of this year, the FDA approved canagliflozin (INVOKANA®) as a single agent as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® has since been widely adopted and today it is the number one branded therapy prescribed by U.S. endocrinologists when adding or switching non-insulin type 2 diabetes medications.
INVOKANA® is the first and only sodium glucose co-transporter 2 (SGLT2) inhibitor available in the United States.
INVOKANA® has been studied as monotherapy and in combination with other type 2 diabetes therapies. The comprehensive global Phase 3 clinical development program for INVOKANA® enrolled 10,285 patients in nine studies and was one of the largest clinical programs in type 2 diabetes submitted to health authorities to date. In clinical studies, patients on INVOKANA® therapy were shown to have greater reductions in A1C as well as greater reductions in body weight and systolic blood pressure versus current standard treatment sitagliptin. A1C is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months.
The most common adverse events with INVOKANA® are genital mycotic (fungal) infections, urinary tract infections and increased urination. These specific adverse events were generally mild to moderate in intensity and infrequently led to discontinuation in Phase 3 studies.
About Type 2 Diabetes
Approximately 25.8 million Americans and an estimated 371 million people worldwide are living with diabetes. Type 2 diabetes comprises 90 percent of people with diabetes, which is chronic and affects the body's ability to metabolize sugar (glucose), and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin.
An estimated 44 percent of the global diabetes burden is attributable to being overweight and obesity. In most people at risk for type 2 diabetes, obesity causes the body to resist the action of insulin, and if the pancreatic beta cells cannot produce enough insulin, hyperglycemia and type 2 diabetes ensue.
Nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control. If left uncontrolled, type 2 diabetes can lead to serious complications. Improved glycemic control has been demonstrated to reduce the onset and progression of these complications.
WHAT IS INVOKANA®?
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT INVOKANA®?
INVOKANA® can cause important side effects, including:
You may be at higher risk of dehydration if you:
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away.
WHO SHOULD NOT TAKE INVOKANA®?
Do not take INVOKANA® if you:
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING INVOKANA®?
Before you take INVOKANA®, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
INVOKANA® may affect the way other medicines work, and other medicines may affect how INVOKANA® works. Especially tell your doctor if you take:
Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is listed above.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
HOW SHOULD I TAKE INVOKANA®?
WHAT ARE THE POSSIBLE SIDE EFFECTS OF INVOKANA®?
INVOKANA® may cause serious side effects, including:
See "What is the most important information I should know about INVOKANA®?"
Signs and symptoms of low blood sugar may include:
The most common side effects of INVOKANA® include:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of INVOKANA®. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Trademarks are those of their respective owners.
About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.
|SOURCE Janssen Research & Development, LLC|
Copyright©2012 PR Newswire.
All rights reserved