GLP-1 is a hormone that helps pancreatic beta cells to secrete insulin in response to high blood sugar. Because it works like the normal hormone, insulin is only secreted when blood sugar is high. Like GLP-1, it also slows gastric emptying. Chemistry
Lixisenatide is a peptide made of 44 amino acids, with an amide group on its C terminus.has been described as "des-38-proline-exendin-4 (Heloderma suspectum)-(1–39)-peptidylpenta-L-lysyl-L-lysinamide", meaning it is derived from the first 39 amino acids in the sequence of the peptide exendin-4, that was isolated from the Gila monster venom, omitting proline at position 38 and adding six lysine residues. Its complete sequence is:
H–His–Gly–Glu–Gly–Thr–Phe–Thr–Ser–Asp–Leu–Ser–Lys–Gln–Met–Glu–Glu–Glu–Ala–Val–Arg–Leu–Phe–Ile–Glu–Trp–Leu–Lys–Asn–Gly–Gly–Pro–Ser–Ser–Gly–Ala–Pro–Pro–Ser–Lys–Lys–Lys–Lys–Lys–Lys–NH2

History
It was created by Zealand Pharma A/S of Denmark; in 2003 Zealand licensed it to Sanofi which developed the drug. Lixisenatide was approved by the European Commission on February 1, 2013. Sanofi submitted an NDA in the US, which was accepted for review by the US FDA in February 2013 but after discussions with the FDA about the cardiovascular safety data included in the package (starting in 2008, the FDA had required stronger CV safety data for new anti-diabetes drugs, following the controversy around the risks of Avandia) Sanofi decided to withdraw the NDA and wait for the results of a Phase III study that was scheduled to be completed in 2015. Because the drug was the first GLP-1 agonist that could be taken once a day, sales projections in 2013 were €500M per year by 2018.
Following this relative lack of success, Dr. Luukkainen replaced the progesterone with the hormone levonorgestrel to be released over a five-year period, creating what is now Mirena.The Mirena IUD was studied for safety and efficacy in two clinical trials in Finland and Sweden involving 1,169 women who were all between 18 and 35 years of age at the beginning of the trials. The trials included predominantly Caucasian women who had been previously pregnant with no history of ectopic pregnancy or pelvic inflammatory disease within the previous year. Over 70% of the participants had previously used IUDs.In 2013 Skyla, a lower dose levonorgestrel IUD effective for up to three years, was approved by the FDA. Skyla has a different bleeding pattern than Mirena, with only 6% of women in clinical trials becoming amenorrheic (compared to approximately 20% with Mirena). The city of Finland, Turku, is currently the only production site for the Mirena contraceptive family. Controversies
In 2009, Bayer, the maker of Mirena, was issued an FDA Warning Letter by the United States Food and Drug Administration for overstating the efficacy, minimizing the risks of use, and making "false or misleading presentations" about the device. From 2000 to 2013, the federal agency received over 70,072 complaints about the device and related adverse effects. As of April 2014, over 1,200 lawsuits have been filed in the United States. References
External links
FDA (2000). "Medical review" (PDF scanned image). Food and Drug Administration.