Eli Lilly and Company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU), recommending approval of Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
The opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on CHMP recommendations within one to two months.
Cialis was approved for erectile dysfunction (ED) in the EU in 2002. Cialis for once daily use was approved for the treatment of ED in the EU in 2007.
"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. "The CHMP positive opinion for Cialis marks an important regulatory milestone for Eli Lilly and Company and our commitment to bringing new treatment options to the millions of men who experience ED and BPH."
Cialis 5 mg for once daily use was approved by the U.S. Food and Drug Administration (FDA) in October 2011 for the treatment of the signs and symptoms of BPH. The FDA also approved Cialis 5 mg for once daily use to treat men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH).
It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain, or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure. It also should not be taken by those who are allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing should call their healthcare provider or get help right away.
In addition to the US, 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.
Cialis is currently approved for ED in more than 100 countries throughout the world.