Development history and fda approval process for adlyxin date. The nda submission for lixisenatide is based on results from the getgoal clinical program, which showed that lixisenatide demonstrated significant reductions in hba1c, a pronounced postprandial glucose ppglowering effect and a beneficial effect on body weight in adult patients with type 2. Adlyxin lixisenatide dose, indications, adverse effects. The fda s esubmitter software is part of an electronic submissions process that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types for. Adlyxin lixisenatide in patients with type 2 diabetes ages 10 to 17 years inclusive that. Adlyxin contains lixisenatide, which acts as a glp1 receptor agonist. Jan 11, 2019 patients may develop antibodies to lixisenatide following treatment with adlyxin. Sanofi announced they are withdrawing their new drug application nda for their oncedaily glp1 lixisenatide from the fda. Lixisenatide for type 2 diabetes the medical letter, inc. Draft soliqua 10033 insulin glargine and lixisenatide injection mg and ifu, received on. Sanofi will resubmit lyxumia for fda approval in q3 follows the glp1 agonists allclear by elixa cardiovascular safety study the first cardiovascular safety study of a glp1 agonist has found no evidence of cardiac risk, hypoglycaemia risk or pancreatic injury.
It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm. Therapy with lixisenatide has not been associated with serum enzyme elevations or with episodes of clinically apparent liver injury. Study on lixisenatide and counterregulation to hypoglycemia the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Glycemic benefits of lixisenatide diabetes in control. Fda advisory panel to discuss new drug application for. We are very pleased to announce the fda acceptance of our submission for lixisenatide in the u. Food and drug administration approved adlyxin lixisenatide, a once daily injection to improve glycemic control blood sugar levels. The use of insulin glarginelixisenatide and lixisenatidecontaining products is not recommended for use while pregnant.
The us food and drug administration fda has approved the once daily subcutaneously injected glucagonlikereceptor glp1 agonist lixisenatide adlyxin. On september 12, sanofi announced that it withdrew the fda application for its oncedaily glp1 agonist lixisenatide named lyxumia in europe for type 2 diabetes. Sanofi will resubmit lyxumia for fda approval in q3 pmlive. Lixisenatide uses, dmf, dossier, manufacturer, supplier. Lixisenatide administration to mice and rats for 2 years resulted in thyroid ccell neoplasia. Dec 25, 20 study on lixisenatide and counterregulation to hypoglycemia the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Food and drug administration fda approved adlyxin lixisenatide, a oncedaily mealtime glp1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. Concerned about migrating your submission platform and data to globalsubmit publish. Food and drug administration approved adlyxin lixisenatide, a oncedaily injection to improve glycemic control blood sugar levels. Submission of software programs to fda submission of software programs to regulatory agencies submission of software programs to regulatory agencies 7. Fda approval history for adlyxin lixisenatide used to treat diabetes, type 2. The nda submission for lixisenatide also includes findings from the elixa study, a longterm cardiovascular cv outcomes study in adults with type 2 diabetes and high cv risk i. Sanofi france new drug application for lixisenatide.
An fda advisory panel will meet today to discuss the safety and efficacy of two new drug applications, 208673 for insulin glargine and lixisenatide injection, to be known as lixilan, and 208471. Side effects include hypoglycemia, dizziness, diarrhea, and headache. Sanofi withdrawing nda for lixisenatide sanofi announced they are withdrawing their new drug application nda for their oncedaily glp1 lixisenatide from the fda. Lixisenatide administered to pregnant rats and rabbits during organogenesis was associated with visceral closure and skeletal defects at systemic exposures that decreased maternal food intake and weight gain during gestation, and that are 1x and 6x higher than the 20mcgday clinical dose, respectively, based on plasma auc. And of course, many more after that for years to come. It is a new drug in the same family as byettabydureon and victoza. Use lixisenatide injection at around the same time every day.
Sep 29, 2015 the us food and drug administration fda has accepted sanofis new drug application nda for lixisenatide, an investigational oncedaily prandial glp1 receptor agonist for the treatment of adults with type 2 diabetes mellitus t2dm, for filing. Adlyxin lixisenatide dosing, indications, interactions. Sep 24, 2019 adlyxin lixisenatide injection, for subcutaneous use. Lyxumia now likely wont be available in the us until 2016 at the earliest, even though it has been approved in europe since february 20. Lixisenatide injection is in a class of medications called incretin mimetics. Submission of software programs to regulatory agencies. Highlights of prescribing information these highlights do not include all the information needed to use adlyxin safely and effectively.
In addition to the general guidance documents listed above, the fda has two documents that provide specific information about the submission of software programs to the fda. Animal pregnancy studies have shown potential risks to the prenate, but it is unclear if these risks are related to the drug. Drug interactions, dosage, and pregnancy and breastfeeding safety information are provided. Nov 18, 2019 lixisenatide alone or in combination with insulin glargine not indicated for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis. Lixisenatide and iglarlixi type 2 diabetes mellitus fda. Patients may develop antibodies to lixisenatide following treatment with adlyxin. This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in premarket submissions for software devices, including standalone software applications and hardwarebased devices that incorporate software. Feb 22, 2016 preparations are on track for regulatory submission in the european union in march 2016.
A regulatory submission to the european union in expected for march 2016. Worried about how much time youll spend on ectd system migration. Adlyxin lixisenatide injection, for subcutaneous use initial u. The nda submission for lixisenatide is based on results from the getgoal clinical program 1,2 and includes findings from the recentlycompleted elixa study, 3 the first completed longterm cv outcomes study. The new drug application nda for lixisenatide was submitted on 20 december 2012. Sanofi announced in lateseptember 2015 that their newest injectable medication for people with type 2 diabetes, named lixisenatide, is now in the early stages of. Lixisenatide lyxumia is recommended as an option for restricted use within nhs wales. Icc 1600655 initiated sponsor submitted new 1 peninjector presentation. Migrating from one system to another is typically a long, expensive and difficult problem. Crossing your fingers that your existing publishing software output will be compatible. The combination of lixisenatide and lantus basal insulin, the investigational lixilan fixedratio product, remains on schedule to enter into phase 3 in the first half of 2014. The fda filing notification for lixisenatide is an important milestone for sanofi, said lixisenatide.
Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Lixisenatide ave0010 is a oncedaily glucagonlike peptide1 glp1 receptor agonist used in the treatment of type 2 diabetes. Adlyxin is contraindicated in patients with known hypersensitivity to lixisenatide or to any component of adlyxin. Other glp1 receptor agonist drug development programs did not use standardized definitions. Glp1 is an important, gutderived, glucose homeostasis regulator that is released after the oral ingestion of carbohydrates or fats. Lixisenatide has been available since 20 in many other countries as lyxumia. There is insufficient data in humans to form a pregnancy risk category for lixisenatide. Lixisenatide was approved by the fda on july 27, 2016 for treatment of type 2 diabetes in adults. The nda submission for lixisenatide is based on results from the getgoal clinical program, which showed that lixisenatide demonstrated significant reductions in hba 1c, a pronounced postprandial glucose ppglowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes. Food and drug administration fda has accepted for filing the new drug application nda for lixisenatide, an investigational oncedaily prandial glp1 receptor agonist for the treatment of adults with type 2 diabetes mellitus t2dm. Lixisenatide is not used instead of insulin to treat people with diabetes who need insulin. Fda advisory panel to discuss new drug application for sanofi. Lixisenatide injection is not used to treat type 1 diabetes condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood.
Adlyxin lixisenatide is a oncedaily prandial glp1 receptor agonist for the treatment of adults with type 2 diabetes mellitus. Compared with exendin4, lixisenatide contains a cterminal modification of the addition of six lysine residues and deletion of a proline that increases its binding affinity to the glp1 receptor and increases its circulating halflife t 12 werner et al. Fda accepts nda for insulin glargine and lixisenatide. Lixisenatide received fda approval on july 28, 2016. Separately, the sanofi executive in charge of diabetes and cardiovascular products, pascale witz, is leaving the. What benefits can lixisenatide provide when added to basal insulin regimen. Lixisenatide is a synthetic analog of endogenous exendin4 that acts as a selective glp1 ra. On july 27, 2015 sanofi aventis us llc submitted a new drug. We are very pleased to announce the fda acceptance of our submission for.
Lixilan an exciting combination of lixisenatide and the basal insulin lantus is still on schedule to begin phase 3 testing in the first half of 2014. Lixisenatide is a recombinant dna produced polypeptide analogue of human glucagonlike peptide1 glp1 which is used in combination with diet and exercise in the therapy of type 2 diabetes, either alone or in combination with other antidiabetic agents. It is usually injected once a day, within one hour 60 minutes before the first meal of the day. Getgoal results also showed that lixisenatide had a favorable safety and tolerability. Jul 16, 2014 lixisenatide ave0010 is a oncedaily glucagonlike peptide1 glp1 receptor agonist used in the treatment of type 2 diabetes. Other glp1 receptor agonist drug development programs did not use standardized. Fda staff question usefulness of sanofi diabetes drugs reuters. Getgoal results also showed that lixisenatide had a favorable safety and tolerability profile in.
Jul 27, 2016 adlyxin lixisenatide is a oncedaily prandial glp1 receptor agonist for the treatment of adults with type 2 diabetes mellitus. The fda has approved lixisenatide sanofi, a shortacting injectable glp1 glucagonlike peptide1 receptor agonist, for oncedaily treatment of adults with type 2 diabetes, both alone adlyxin and in a fixedratio combination with insulin glargine soliqua 10033. Listing a study does not mean it has been evaluated by the u. Mar 19, 2015 results of the cardiovascular outcomes trial with the glp1 agonist lixisenatide are to be presented at the june ada meeting, and sanofi plans to resubmit the product to the us fda. Content of premarket submissions for software contained in. May 23, 2016 an fda decision on lixisenatide is expected in july and on iglarlixi in august. Hypersensitivity reactions including anaphylaxis have occurred with adlyxin see warnings and precautions 5. Sanofi withdraws lyxumia submission from the fda, plans for. Dailymed adlyxin lixisenatide kit adlyxin lixisenatide. Sanofi snags fda panels support for new oncedaily diabetes combo iglarlixi read this article along with other careers information, tips and advice on biospace. Lixisenatide is a peptide containing 44 amino acids, which is amidated at the cterminal amino acid position 44. Lixisenatide injection comes as a prefilled dosing pen to inject subcutaneously under the skin. Study on lixisenatide and counterregulation to hypoglycemia. In september 2015, the fda accepted the nda for lixisenatide and a decision is anticipated in july 2016.
Fda accepts sanofi new drug application for oncedaily fixed. Paris, july 27, 2016 prnewswire sanofi announced today that the u. Highlights of prescribing information pancreatitis. The use of insulin glarginelixisenatide and lixisenatide containing products is not recommended for use while pregnant. The us food and drug administration fda has approved the once daily subcutaneously injected glucagonlikereceptor glp1 agonist lixisenatide adlyxin, sanofi for the treatment of adults with. Submission to the us food and drug administration fda is planned for july 2015. A pooled analysis of studies of lixisenatide treated patients showed that 70% were antibody positive at week 24. Sanofi withdraws lyxumia submission from the fda, plans. Key evidence pinget m, goldenberg r, niemoeller e et al. In 2010, zeland and sanofi extended their license agreement to allow sanofi to develop a combination therapy of lixisenatide with insulin glargine, which was sanofis best selling drug at the time, with sales of around 3 billion in 2009. Fda and are still used exclusively by the agency to evaluate 100% of the electronic submissions it receives click here to request synchrogenixs globalsubmit software pricing.
Lixisenatide adlyxin is a drug prescribed to treat type 2 diabetes in conjunction with diet and exercise. Results of the cardiovascular outcomes trial with the glp1 agonist lixisenatide are to be presented at the june ada meeting, and sanofi plans to resubmit the product to the us fda. If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot. Lixisenatide lyxumia should be restricted for use in the following circumstances within its licensed indication for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucoselowering medicinal products andor basal insulin when these, together. Lixisenatide alone or in combination with insulin glargine not recommended for use in patients with gastroparesis. Sanofi receives fda approval of adlyxintm for treatment of. Lixisenatide and iglarlixi insulin glarginelixisenatide. Additional data or analysis required for a previously submitted or.
The fdas esubmitter software is part of an electronic submissions process that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types within the drug, blood, device, radiological health, tobacco, animal drug and animal food regulated industries. Glp1 agonist lixisenatide adlyxin okayed for t2dm in us. All wales medicines strategy group awmsg lixisenatide. The nda for lixisenatide was accepted in september 2015, and an fda decision is anticipated in july 2016. In the past couple months, there have been several new treatments for type 1 and type 2 diabetes receiving fda approval, and in the near future, there will likely be another.
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