By Josh Beckerman
Eli Lilly & Co.'s (LLY) 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.
Write to Josh Beckerman at josh.beckerman@wsj.com
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