New uses of Cialis, Votubia, Galvus, Eucreas and Eliquis backed by CHMP, but not Qsiva

Among a batch of recommendations resulting in meetings last week from the European Medicines Agency’s  Committee for Medicinal Products for Human Use (CHMP) was one for US drug major Eli Lilly’s (NYSE: LLY) erectile dysfunction drug Cialis (tadalafil), for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in the European Union.

"If approved by the European Commission, Cialis will be the only medication in the EU to provide a single treatment option for men with both ED and BPH," said Anthony Beardsworth, senior medical director at Lilly, adding that "the CHMP positive opinion for Cialis marks an important regulatory milestone for Eli Lilly and our commitment to bringing new treatment options to the millions of men who experience ED and BPH."

Cialis brought in $1.88 billion last year, and is Lilly’s fifth-best-selling product.Cialis for once daily use was approved by the US Food and Drug Administration in October 2011 for the treatment of the signs and symptoms of BPH. The FDA also approved Cialis for once daily use to treat men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH). In addition to the USA, Cialis for once daily use has been approved to treat the signs and symptoms of BPH in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel.