Eli Lilly and Companys (LLY) Cialis (tadalafil) recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (:EMA). The CHMP issued an opinion in favor of approving Eli Lillys erectile dysfunction (ED) drug, Cialis (5 mg), for the once-daily treatment of the signs and symptoms of benign prostatic hyperplasia (:BPH). A response from the European Commission regarding Cialis regulatory status should be out in two months. The CHMPs opinion was based on a review of safety and efficacy data on 1,500 patients from four clinical studies of BPH, including a study of BPH and ED. Cialis label expansion would provide patients suffering from both ED and BPH with a new treatment option. Approval for the additional indication will help boost Cialis sales, which came in at $1.9 billion in 2011. Cialis, which is approved for the treatment of ED in the EU, is approved for the treatment of ED as well as the treatment of BPH in the US. Cialis main competitors in the ED market include Pfizers (PFE) Viagra and GlaxoSmithKlines (GSK) Levitra. The BPH market is also pretty crowded with products like Glaxo's Avodart and Jalyn, Sanofis (SNY) … Continue reading
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