Astellas set for more Vesomni approvals after Netherlands nod
This article was originally published in Scrip
Astellas Pharma has secured marketing authorisation for its combination urology drug, Vesomni, in its first market, the Netherlands, which will now act as the reference member state for further approvals throughout Europe under the mutual recognition procedures.
The product (formerly EC905) is a once-daily treatment containing 6mg of the antimuscarinic solifenacin and 0.4mg of the alpha1-adrenoceptor antagonist tamsulosin (in an oral controlled-absorption system).
The news follows an approval filing made in March last year (scripintelligence.com, 28 March 2012) and Astellas will be hoping that European approval will boost its flagging tamsulosin franchise.
The Dutch Medicines Evaluation Board gave its go-ahead for the use of Vesomni for moderate-to-severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy.
Solifenacin is also already marketed alone in Europe as Vesicare, for the treatment of overactive bladder symptoms.