Lilly receives CHMP backing for BPH therapy Cialis

Lilly has been granted a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for approval of the benign prostatic hyperplasia (BPH) drug Cialis.

The tablet-based treatment has been endorsed as a once-daily therapy for the signs and symptoms of BPH, following on from its approval in the US for the same indication last year.

Cialis has been available in the EU since 2002 as a treatment for erectile dysfunction, receiving an additional approval for once-daily administration in 2007.

The CHMP's opinion will now be referred to the European Commission ahead of a final approval decision, which is expected within the next month or two.

Anthony Beardsworth, senior medical director at Lilly, said: "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."

This comes after Lilly and partner Boehringer Ingelheim received a recommendation from the CHMP for regulatory approval of an expanded indication for the diabetes drug Trajenta last week.