INDIANAPOLIS, Sept. 21, 2012 -- Eli Lilly and Company (NYSE: LLY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Cialis (tadalafil) tablets 5 mg for once a day use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
The CHMP's opinion is now referred to the European Commission, which has the authority to approve medicines for the European Union (EU). The Commission usually issues a decision within one to two months following the CHMP opinion.
Tadalafil was approved for the treatment of erectile dysfunction in the EU in 2002. Tadalafil for once a day use was approved for the treatment of erectile dysfunction in the EU in 2007.
"If approved by the Commission, tadalafil will be the first and only medication approved in the EU to treat men with both erectile dysfunction and benign prostatic hyperplasia," said Kraig Kinchen, M.D., senior medical director at Lilly. "Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians."
The CHMP issued its opinion after reviewing safety and efficacy data from 1,500 patients in four clinical studies of BPH, including one study of BPH and ED. Additionally, safety data from the approved indication for erectile dysfunction were included in Lilly's submission. In the BPH and ED study, Cialis 5 mg for once a day use significantly improved scores on the International Prostate Symptom Score (IPSS), a questionnaire evaluating symptoms of BPH, and the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), a questionnaire evaluating sexual function.
PR Newswire