The CHMP has decided in favour of Almirall’s silodosin, recommending the granting of marketing authorisations for the medicinal products Urorec and Silodyx hard capsules for treatment of the symptoms of benign prostatic hyperplasia (BPH).
The European Commission’s decision is expected within 67 days from adoption of the CHMP opinion.
In April this year Almirall signed a co-marketing agreement with Recordati, which granted Almirall the marketing rights for silodosin in Spain under the trademark Silodyx. The agreement enables Almirall to strengthen its core business over the coming years and reinforce its product pipeline in the urology area.
Silodosin is a urological medicinal product. The active ingredient is a selective α1A- antagonist of the adrenoreceptors. Blockade of these receptors causes smooth muscle in the prostate, urinary bladder base and neck and prostatic capsule and prostatic urethra to relax, thus decreasing the bladder outlet resistance associated with BPH.
The compound was originally developed by Kissei Pharmaceutical in Japan, and has been obtained under licence by Recordati for the whole of Europe (45 countries) and a further 18 countries in the Middle East and Africa.
Silodosin is currently available in North America, Japan and other countries in Asia.
Almirall is an international pharmaceutical company headquartered in Barcelona, Spain. It researches, develops, manufactures and commercialises its own R&D and licensed drugs in the therapeutic areas of asthma, COPD, rheumatoid arthritis, multiple sclerosis, psoriasis and other dermatological conditions.