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In July 2009, the FDA approved colchicine as a monotherapy for the treatment of three different indications (familial Mediterranean fever, acute gout flares, and for the prophylaxis of gout flares [66]). This resulted in a 3-year regulatory market exclusivity in the acute and chronic gout indications and a 7-year exclusivity on the FMF indication.
[15] [16] 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. [16] Sanofi resubmitted the application which the FDA accepted in September 2015, by which time Sanofi had lost the lead in the field of anti-diabetic drugs to Novo Nordisk. [17]
Drugs used in diabetes treat types of diabetes mellitus by decreasing glucose levels in the blood. With the exception of insulin , most GLP-1 receptor agonists ( liraglutide , exenatide , and others), and pramlintide , all diabetes medications are administered orally and are thus called oral hypoglycemic agents or oral antihyperglycemic agents.
Although the exact mechanism of colchicine is not fully understood, its anti-inflammatory effect for pericarditis appears to be related to its ability to inhibit microtubule self-assembly, resulting in decreased leucocyte motility and phagocytosis. Other non-FDA-approved uses include actinic keratosis, amyloidosis, Peyronie's disease, and ...
Lilly's Mounjaro has been on the U.S. FDA's shortage list since late 2022, while Zepbound was added to the list in April this year. US FDA says all doses of Lilly's weight-loss and diabetes drug ...
In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with locally advanced or metastatic non- small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2]
Novo is aiming to be the first to hit the market with a weekly insulin product, offering an alternative for patients with type 1 and type 2 diabetes who now depend on multiple daily injections.
Insulin glargine/lixisenatide is approved as a prescription for adults with type 2 diabetes mellitus poorly controlled by lixisenatide or basal insulin alone. [6] According to the American Diabetes Association, combination treatment of a GLP-1 receptor agonist with basal insulin should occur after HbA1C levels remain above target (7% for most type 2 people with diabetes) following use of basal ...
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