FDAnews Drug Daily Bulletin


Dec. 20, 2005

Eli Lilly plans to seek expanded approval for its antidepressant Cymbalta -- a drug that is already reaping better-than-expected results for the company.

Lilly plans to file a supplemental new drug application with the FDA in early 2006 seeking approval for Cymbalta (duloxetine HCl) as treatment for generalized anxiety disorder. The drug received FDA approval in 2004 to treat major depression and to help manage diabetic nerve pain.

The new indication would drive further growth for Cymbalta, which through the first nine months of 2005 generated sales of $450.9 million. "Despite an overall flat U.S. antidepressant market in 2005, Cymbalta has led all branded and promoted products in share-of-market growth during this period," Lilly Chairman and CEO Sidney Taurel said recently. "In addition, the product is launching very strongly overseas. For example, Cymbalta had the best antidepressant launch ever in Germany."

Cymbalta's strong performance combined with improved sales of Lilly's schizophrenia drug Zyprexa (olanzapine) prompted the company to raise its 2006 earnings forecast by a whopping 63 percent. Lilly expects its net income for next year will increase to $3.10 to $3.20 per share, up from an October forecast of $1.90 to $1.96 per share.

Zyprexa revenues slumped during the first two quarters of the year due to increased competition from Johnson & Johnson's Risperdal (risperidone) and AstraZeneca's Seroquel (quetiapine fumarate), but sales of Lilly's drug rose 1.1 percent to $1 billion during the third quarter.

"We are somewhat encouraged by Zyprexa's recent U.S. performance where the erosion of Zyprexa prescriptions slowed in recent months," said John Lechleiter, Lilly's president and chief operating officer. "Our goals are to further stabilize U.S. Zyprexa sales and sustain modest growth on a global basis."