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EU approves Lyxumia (Lixisenatide), SANOFI, for the treatment of type 2 diabetes

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CAS # 320367-13-3, Lixisenatide

Sun feb3, 2013, Sanofi today announced its novel once daily GLP-1 – Lyxumia has been approved by EU authorities.Lyxumia is the fourth GLP-1 and the second once daily GLP-1 to reach the market. Lyxumia is distinguished from other GLP-1’s on the market by virtue of its superior post prandial glucoselowering impact. Like other GLP-1’s it has a positive impact on hypoglycemia rates and weight lowering.

The European Commission decision to grant Marketing Authorisation in Europe for Lyxumia® is based on results from the GetGoal clinical programme, which enabled Lyxumia® to be the first once-daily GLP-1 receptor agonist with a predominantly prandial glucose lowering effect to be indicated for use on top of basal insulin and in combination with oral anti-diabetic medications. The clinical programme showed that Lyxumia® demonstrated significant HbA1c reductions, a pronounced post-prandial glucose lowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes. GetGoal results also showed that Lyxumia® had a favourable safety and tolerability profile in most patients, with mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycaemia. The international GetGoal programme included 11 clinical trials involving more than 5,000 patients with type 2 diabetes, with a large number of patients studied to evaluate a GLP-1 receptor agonist in combination with basal insulin (706 patients treated with Lyxumia® in three trials).

READ  OLD ARTICLE AT

http://amcrasto.theeurekamoments.com/2012/11/19/sanofi-receives-positive-chmp-opinion-in-the-european-union-for-once-daily-lyxumia-lixisenatide/

str from chemblink Online Database of Chemicals from Around the World

CAS # 320367-13-3, Lixisenatide

OLD ARTICLE

Sanofi Receives Positive CHMP Opinion in the European Union for Once-Daily Lyxumia® (lixisenatide)

Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of once-daily Lyxumia® (lixisenatide) for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002445/smops/Positive/human_smop_000448.jsp&mid=WC0b01ac058001d127

Lixisenatide is a once-daily injectable GLP-1 receptor agonist that has been developed by Sanofi.[1] As of September 2010 it is in clinical trials for diabetes.[2]

Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus. Lixisenatide was discovered by Zealand Pharma A/S and the global rights are licensed to Sanofi. Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.

GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for type 2 diabetes and their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology.

The GetGoal phase III clinical program will provide data for lixisenatide in adults with type 2 diabetes treated with various oral anti-diabetic agents or insulin. With ten trials in the program, GetGoal started in May 2008 and has enrolled more than 4,300 patients. To date, GetGoal-X, GetGoal-L, GetGoal-L Asia, GetGoal-Mono, GetGoal-S and GetGoal-F1 have reported positive top-line results supporting efficacy and safety for lixisenatide

  1. Christensen, M; Knop, FK; Holst, JJ; Vilsboll, T (2009). “Lixisenatide, a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus”. IDrugs : the investigational drugs journal 12 (8): 503–13. PMID 19629885.
  2. http://www.genengnews.com/gen-news-highlights/positive-phase-iii-data-for-two-separate-type-2-diabetes-therapies-reported-at-esad/81243945/

Sanofi Submits Application for Regulatory Approval for Lyxumia
®
(lixisenatide) for the Treatment of Type 2 Diabetes in Japan

Figures&figureshttp://en.sanofi.com/Images/30529_20120611_LYXUMIA-JAPAN_en.pdf

Lixisenatide Structure

CAS No. 320367-13-3
Chemical Name: Lixisenatide
Synonyms: lixisenatide
CBNumber: CB01518519
Molecular Formula:

Formula Weight: 4858.53
C215H347N61O65S

3 Comments

  1. RAMKUMAR GAUR says:

    Its very usefull to humanity and all people gained profit to all patients ,
    very Thanks to dr Anthony

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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