PARIS, July 27, 2016 /PRNewswire/ — Sanofi announced today that the U.S. Meals and Drug Administration (FDA) approved AdlyxinTM (lixisenatide), a once-everyday mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet plan and workout for the treatment of adults along with type 2 diabetes.
“The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by individuals living along with diabetes as soon as attempting to reach and sustain their personal blood glucose (HbA1c) targets,” said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardio Business Unit, Sanofi. “We are pleased along with this approval, as it offers us the opportunity to go on aiding patients treated along with basal insulin that stay uncontrolled.”
The approval of Adlyxin was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which successfully addressed the FDA’s request to demonstrate CV safety. The GetGoal clinical program, which included 13 clinical trials involving Much more compared to 5,000 adults along with type 2 diabetes worldwide, evaluated the safety and efficacy of lixisenatide in adults along with type 2 diabetes. every one of studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common side events reported for Adlyxin included nausea, hypoglycemia and vomiting.
Adlyxin will certainly be available in a disposable pre-filled pen in a single dose of 20 micrograms. Patients will certainly likewise receive a disposable pre-filled pen in a single dose of 10 micrograms that they must initiate once everyday for 14 days. On Day 15, patients will certainly raise dosage to 20 micrograms once daily.
Adlyxin is approved under the proprietary name, Lyxumia® in Much more compared to 60 countries and marketed in over 40. Commercial launches include most EU countries, Japan, Brazil, Mexico and India. Adlyxin was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), http://ift.tt/11w56m8.
About Adlyxin
Adlyxin is a once-everyday glucagon-adore peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients along with type 2 diabetes mellitus as an adjunct to diet plan and exercise. GLP-1 is a peptide hormone that is released within minutes after consuming a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Adlyxin boosts glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.
Indication and Usage
What is Adlyxin (lixisenatide) injection?
Adlyxin is an injectable prescription medicine that could improve blood sugar (glucose) control in adults along with type 2 diabetes, as soon as used along with diet plan and exercise.
- Adlyxin is not insulin and must not be used rather than a long-acting insulin.
- Adlyxin is not for individuals along with type 1 diabetes or individuals along with diabetic ketoacidosis.
- Adlyxin has actually not been studied in individuals along with a history of pancreatitis.
- Adlyxin has actually not been studied in individuals that use short-acting insulin.
- It is not known if Adlyxin is safe and effective in children.
Important Safety Post for Adlyxin (lixisenatide) injection
What is the essential Post I must know Regarding Adlyxin?
Do not share your Adlyxin pen along with others people, even if the needle has actually been changed. You could offer others individuals a serious infection, or get hold of a serious infection from them.
Adlyxin can easily trigger serious edge effects, including:
- inflammation of the pancreas (pancreatitis), which might be severe and lead to death. Stop using Adlyxin and call your healthcare provider right away if you have actually severe pain in your stomach area (abdomen) that will certainly not go away, along with or devoid of vomiting. You could feel pain from your abdomen to your back.
Do not use Adlyxin if you:
- are allergic to lixisenatide or any kind of of the others ingredients in Adlyxin.
Symptoms of severe allergic reaction along with Adlyxin could include swelling of your face, lips, tongue, or throat, complications breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and rather rapid heartbeat.
Before using Adlyxin, tell your healthcare provider if you:
- have or have actually had pancreatitis, stones in your gallbladder, or a history of alcoholism.
- have or have actually had kidney problems.
- have severe complications along with your stomach, such as delayed emptying of your stomach (gastroparesis) or complications along with digesting food.
- are pregnant or breastfeeding or strategy to become pregnant or breastfeed. It is not known if Adlyxin will certainly harm your unborn baby.
Tell your healthcare provider Regarding every one of the medicines you take, including prescription medicines (especially antibiotics and birth regulate pills) and over-the-counter medicines (especially acetaminophen), vitamins, herbal supplements or others medicines to treat diabetes, including sulfonylureas or insulin.
How must I use Adlyxin?
- Check the label on the pen each time you offer your Adlyxin injection to make certain you are using the proper medication.
- You need to activate each Adlyxin pen Prior to you use it for the initial time.
- Do not re-use or share your needles along with others people. You could offer others individuals a serious infection, or get hold of a serious infection from them.
- Inject your dose of Adlyxin under the skin (subcutaneously) of your abdomen, thigh, or upper arm. Do not inject in to a vein.
- Change (rotate) your injection sites within the area you chose along with each dose. Do not use the same spot for each injection.
What are the feasible edge effects of Adlyxin?
Adlyxin could trigger serious edge effects including:
- severe allergic reactions. Severe allergic reactions can easily happen along with Adlyxin. Stop taking Adlyxin and get hold of medical suggestions right away if you have actually any kind of symptoms of a severe allergic reaction.
- low blood sugar (hypoglycemia). Your risk for getting reduced blood sugar is better if you use Adlyxin along with one more medicine that can easily trigger reduced blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin medicine could should be lowered while you use Adlyxin. Signs and symptoms of reduced blood sugar could include headache, drowsiness, weakness, hunger, fast heartbeat, dizziness, confusion, irritability, sweating and feeling jittery.
Talk along with your healthcare provider Regarding Exactly how to treat reduced blood sugar.
The most common edge effects of Adlyxin include:
- nausea, vomiting, headache, diarrhea and feeling dizzy.
Please click here for full Prescribing Post for Adlyxin: http://ift.tt/2ajm5q9.
About Sanofi Diabetes & Cardiovascular
Diabetes and Cardio health problem affect millions of individuals worldwide, along with numerous managing the complex challenges of both. Building on our portfolio evolution, heritage and expertise, Sanofi has actually a focused business unit dedicated to delivering innovative, value-based medicines and integrated solutions in these therapeutic areas. We are committed to a collaborative approach that entails strategic alliances along with professional and patient associations, research institutions and leaders in healthcare and others industries, along with the Target of advancing scientific knowledge, driving the convergence of science and technology, aiding to improve outcomes and inspiring an evolution in care.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized in to 5 global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in Paris (EURONEXT: SAN) and in Brand-new York (NYSE: SNY).
Sanofi Forward-Looking Statements
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