FDA expands indication for Soliqua® 100/33

BRIDGEWATER, N.J., Feb. 27, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved the expanded use of Soliqua^® 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL. Previously approved for use as an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on long-acting insulin or lixisenatide, Soliqua 100/33 can now also be prescribed for patients uncontrolled on oral antidiabetic medicines.

"Many people living with type 2 diabetes are uncontrolled on diet and exercise alone and could require additional interventions to help lower their blood sugar levels," said Michelle Carnahan, North America Head of Primary Care, Sanofi. "This FDA decision marks the first combination insulin and GLP-1 injectable medicine approved for adults living with type 2 diabetes who are uncontrolled with diet and exercise, potentially providing them access to an option that can help them achieve their treatment goals."

The FDA approval was based on data from the LixiLan-O clinical trial which showed, in adults with type 2 diabetes uncontrolled with metformin and/or a second oral antidiabetic therapy, that treatment with Soliqua 100/33 led to significantly greater reductions in blood sugar levels compared with insulin glargine and lixisenatide (-1.6%, -1.3%, -0.9%, respectively; p<0.0001). In addition, significantly more patients reached their target blood sugar levels with Soliqua 100/33 (74%) compared with insulin glargine (59%) or lixisenatide (33%). Low blood sugar events were similar between Soliqua 100/33 (25.6%) and insulin glargine (23.6%), but were lower with lixisenatide (6.4%). The most common adverse events generally at the beginning of treatment in the Soliqua 100/33 arm were nausea (9.6%) and vomiting (3.2%).

Sanofi will continue offering its savings program for Soliqua 100/33 which can limit out-of-pocket expenses sometimes to $0 for all commercially insured patients regardless of formulary status on an insurance plan or income level. For more information about this program, visit www.soliqua100-33.com.

About Soliqua 100/33

Soliqua 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.

• It has not been studied in people with a history of pancreatitis.
• It is not recommended for people who also take lixisenatide or other medicines called GLP-1 receptor agonists.
• It is not for use in people with type 1 diabetes, or people with diabetic ketoacidosis.
• It has not been studied in people who have a stomach problem that causes slow emptying (gastroparesis) and is not for people with slow emptying of the stomach.
• It has not been studied in people who also take a short-acting (prandial) insulin.
• It is not known if Soliqua 100/33 is safe and effective in children under 18 years of age.

Important Safety Information for Soliqua® 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL

What is the most important information I should know about Soliqua 100/33?
Do not share your Soliqua 100/33 pen 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.

Soliqua 100/33 can cause serious side effects, including inflammation of the pancreas, which may be severe and lead to death.

Before using Soliqua 100/33, tell your doctor if you have had pancreatitis, stones in your gallbladder (cholelithiasis), or a history of alcoholism.  These medical problems may make you more likely to get pancreatitis.

Stop taking Soliqua 100/33 and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.

Who should not use Soliqua 100/33?

Do not use Soliqua 100/33 if you:

• are having an episode of low blood sugar (hypoglycemia)
• are allergic to insulin glargine, lixisenatide, or any of the ingredients in Soliqua 100/33. Symptoms of a severe allergic reaction with Soliqua 100/33 may include swelling of the face, lips, tongue, or throat, fainting or feeling dizzy, problems breathing or swallowing, very rapid heartbeat, severe rash or itching, or low blood pressure.

Before using Soliqua 100/33, tell your healthcare provider about all your medical conditions, including if you:

• have or have had problems with your pancreas, your kidneys, or your liver, stones in your gallbladder, or a history of alcoholism.
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take thiazolidinediones (TZDs).
• have severe problems with your stomach, such as slowed emptying of your stomach or problems digesting food.
• are taking certain medicines called glucagon-like peptide 1 receptor agonists (GLP-1 receptor agonists).
• have had an allergic reaction to a GLP-1 receptor agonist.
• are pregnant or breastfeeding or plan to become pregnant or to breastfeed. It is not known if Soliqua 100/33 will harm your unborn baby or pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements. Soliqua 100/33 may affect the way some medicines work. Before using Soliqua 100/33, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use Soliqua 100/33?

• Do not change your dose without first talking to your healthcare provider.
• Check the pen label each time you inject to make sure you are using the correct medicine.
• Do not take more than 60 units of Soliqua 100/33 each day. Do not take Soliqua 100/33 with other GLP-1 receptor agonists.
• Only use Soliqua 100/33 that is clear and colorless to almost colorless. If you see small particles, return it to your pharmacy for replacement.
• Do not remove Soliqua 100/33 from the pen with a syringe.
• Do not re-use or share needles with other people. You may give other people a serious infection, or get a serious infection from them.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check.

What are the possible side effects of Soliqua 100/33?
Soliqua 100/33 may cause serious side effects, including:

• Serious allergic reactions. Stop taking Soliqua 100/33 and get help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar may include headache, dizziness, drowsiness, sweating, weakness, irritability, hunger, blurred vision, fast heartbeat, feeling jittery, confusion, and anxiety.
• Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may worsen kidney problems.
• Low potassium in your blood (hypokalemia).
• Heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Soliqua 100/33 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with Soliqua 100/33. Tell your healthcare provider if you have any new or worse symptoms of heart failure, including shortness of breath, swelling of your ankles or feet, or sudden weight gain. Treatment with TZDs and Soliqua 100/33 may need to be adjusted or stopped if you have new or worse heart failure.

The most common side effects of Soliqua 100/33 include low blood sugar (hypoglycemia), nausea, diarrhea, upper respiratory infection, stuffy or runny nose, and headache.  Nausea and diarrhea usually happen more often when you first start using Soliqua 100/33.

Click here for Full Prescribing Information for Soliqua 100/33.

Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)

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