Sixth approval for Lilly’s Cymbalta

Eli Lilly has received yet another approval for its blockbuster Cymbalta from regulators in the USA.

The Food and Drug Administration has approved Cymbalta (duloxetine) for the maintenance treatment of generalised anxiety disorder in adults. This is the sixth green light for the drug, as it is already approved for the acute and maintenance treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain and fibromyalgia, as well as for the acute treatment of GAD.

This latest approval is based on a 419-patient study which showed that patients taking Cymbalta experienced a statistically significantly longer time to relapse of GAD than did patients taking placebo. The estimated probability of relapse at 26 weeks of maintenance treatment was 46.4% for placebo and 15% for Lilly’s drug.

James Martinez, US medical director for Cymbalta, noted that since generalised anxiety disorder can be a chronic illness, it is important to find a treatment option “that is effective in both the acute and maintenance phase of treatment". GAD affects nearly seven million Americans and getting the maintenance therapy approval should push up Cymbalta’s already-considerable sales. Third-quarter revenues from the drug were up 10% to $790.2 million.