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Lilly’s Cialis receives EU endorsement for new use

By R&D Editors | September 21, 2012

A European committee has endorsed the use of Eli Lilly and Co.’s erectile dysfunction drug Cialis to treat symptoms tied to a condition that leads to an enlarged prostate.

The European Union’s Committee for Medicinal Products for Human Use recommended approval of a 5-milligram dose of Cialis to treat benign prostatic hyperplasia. The European Commission usually decides on the committee’s opinion within a month or two, Lilly said Friday. It doesn’t have to follow the recommendation but often does.

The Food and Drug Administration approved the additional use for Cialis in the United States last fall. It also has been approved in Canada, Mexico and Brazil, among other countries.

Benign prostatic hyperplasia is a condition that can lead to an enlarged prostate, which causes symptoms like the need to urinate urgently and frequently.

Cialis brought in $1.88 billion last year, or 8 percent of Lilly’s total revenue, as its fifth-best-selling product.

Shares of the Indianapolis drugmaker climbed 43 cents to $47.45 in Friday morning trading, while broader trading indexes also climbed less than 1 percent.

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