Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc announced that the U.S. FDA granted approval for Basaglar 100 units/mL. BASAGLAR is a long-acting insulin with an identical amino acid sequence to Lantus®, another U-100 insulin glargine.
BASAGLAR is indicated to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes. BASAGLAR should not be used to treat diabetic ketoacidosis. BASAGLAR should not be used during episodes of low blood sugar (hypoglycemia) or in people with an allergy to insulin glargine or any of the ingredients in BASAGLAR.
"Lilly has a long history of developing and manufacturing insulin, having introduced the world's first commercial insulin more than 90 years ago," said David Kendall, MD, vice president, Global Medical Affairs, Lilly Diabetes. "BASAGLAR will be a welcome addition to our insulin and alliance portfolios, offering an option for people with diabetes who may need a long-acting insulin."
The BASAGLAR FDA approval is based, in part, upon an extensive clinical development program. The submission included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in people with type 1 and type 2 diabetes comparing the safety and efficacy of BASAGLAR to U.S.- and non-U.S.-approved Lantus.
The FDA approval follows BASAGLAR's tentative U.S. approval in August 2014, which was contingent upon patent litigation resolution. Per the settlement agreement with Sanofi, BASAGLAR will be available in the U.S. starting on December 15, 2016.
"The BASAGLAR FDA approval marks the first insulin therapy to be approved in the U.S. as part of our alliance with Lilly and broadens our portfolio of treatment options for people with type 1 and type 2 diabetes," said Paul Fonteyne, president and CEO, BIPI. "We remain committed to the care of people with diabetes and look forward to a successful U.S. launch of BASAGLAR."
This latest regulatory approval is the 11th for BASAGLAR worldwide, with launches taking place in several countries this year, including under the trade name Abasaglar® in Europe.
BASAGLAR is a long-acting, man-made insulin indicated to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes.
BASAGLAR should not be used to treat diabetic ketoacidosis.
IMPORTANT SAFETY INFORMATION for BASAGLAR®
What is the most important information I should know about BASAGLAR?
- Do not share your BASAGLAR KwikPen® with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
- Do not change the insulin you use without talking to your healthcare provider. Changes may make you more likely to experience low or high blood sugar. Changes should be made cautiously under the supervision of your healthcare provider.
- Test your blood sugar levels as your healthcare provider instructs.
- Your insulin dose may need to change because of illness, stress, other medicines you take, change in diet, or change in physical activity or exercise.
Who should not take BASAGLAR?
- Do not use BASAGLAR if you are having an episode of low blood sugar (hypoglycemia) or have an allergy to any of the ingredients in BASAGLAR.
- It is not known if BASAGLAR is safe and effective in children less than six years of age with type 1 diabetes mellitus or in children with type 2 diabetes mellitus.
What should I tell my healthcare provider before using BASAGLAR?
Before using BASAGLAR, tell your healthcare provider about all your medical conditions, including if you:
- have liver or kidney problems.
- take any other medicines, especially ones called TZDs (thiazolidinediones).
- have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with BASAGLAR.
- are pregnant, planning to become pregnant, or are breastfeeding. BASAGLAR may harm your unborn or breastfeeding baby.
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Before you start using BASAGLAR, talk with your healthcare provider about low blood sugar and how to manage it.
How should I use BASAGLAR?
- Read the detailed Instructions for Use that come with your BASAGLAR KwikPen®.
- Use BASAGLAR exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much BASAGLAR to use and when to use it.
- Know the amount of BASAGLAR you use. Do not change the amount of BASAGLAR you use unless your healthcare provider tells you to.
- Check your insulin label each time you give your injection to make sure you are using the correct insulin.
- BASAGLAR may be used any time during the day, but BASAGLAR should be used at the same time each day.
- Only use BASAGLAR that is clear and colorless. If your BASAGLAR is cloudy or slightly colored, return it to your pharmacy for a replacement.
- BASAGLAR is injected under your skin (subcutaneously). Do not use BASAGLAR in an insulin pump or inject BASAGLAR in your vein (intravenously).
- Change (rotate) your injection sites within the area you chose for each dose. Do not use the exact spot for each injection.
- Do not mix BASAGLAR with any other type of insulin.
- Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
- While using BASAGLAR, do not drive or operate heavy machinery until you know how BASAGLAR affects you; and do not drink alcohol or use over-the-counter medicines that contain alcohol.Keep BASAGLAR and all medicines out of the reach of children.
What are the possible side effects of BASAGLAR?
BASAGLAR may cause serious side effects that can lead to death, including:
- Low blood sugar (hypoglycemia). Signs and symptoms may include dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood change, or hunger.
- Severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs of allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
- Low potassium level in your blood (hypokalemia).
- Heart failure. Taking certain diabetes pills thiazolidinediones or "TZDs" with BASAGLAR may cause heart failure in some people, even in people who have never had heart failure or heart problems before. If you have already had heart failure it may get worse if you take TZDs with BASAGLAR. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of the ankles or feet, or sudden weight gain. Treatment with TZDs and BASAGLAR may need to be changed or stopped by your healthcare provider.
- Get emergency help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.
- The most common side effects of BASAGLAR include low blood sugar (hypoglycemia), allergic reactions, including reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy). These are not all of the possible side effects. Ask your healthcare provider for more information or for medical advice about side effects.