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Eli Lilly & Co.'s Type 2

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TREND1 Member Level  Friday, 10/24/14 12:16:23 AM
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Eli Lilly & Co.'s Type 2 diabetes drug Trulicity has been approved by the U.S. Food and Drug Administration, the agency said Thursday. The drug is a subcutaneous injection that helps improve blood-sugar levels. Lilly plans to launch Trulicity 0.75 mg and 1.5 mg single-dose pens later this year, the company said Thursday. This is the first regulatory approval for the drug, which has been submitted to other regulators including the European Medicines Agency and other regulatory bodies. The FDA is requiring certain post-marketing studies for Trulicity, including a clinical trial to evaluate effectiveness and safety in pediatric patients. After the company met with analysts to discuss the drug in June, J.P. Morgan estimated Trulicity would post about $1.4 billion in 2020 sales. Trulicity, or dulaglutide, belongs to a class of drugs called GLP-1 receptor agonists, which work by stimulating the body's natural production of insulin and help regulate blood-sugar levels. Lilly said in February that the drug was comparable to Novo Nordisk A/S's (NVO) once-daily Victoza in reducing a measure of blood sugar in a patient study.

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