Drugs Xagena
On 18 October 2012, the CHMP ( Committee for Medicinal Products for Human Use ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Betmiga, 25 mg, 50 mg, prolonged-release film-coated tablet intended for symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in patients with overactive bladder ( OAB ) syndrome.
The active substance of Betmiga is Mirabegron, a urological.
Mirabegron is a selective agonist for human beta-3 adrenoceptor ( beta-3 AR ) which is dominant in the human detrusor muscle. Activation of the beta-3 AR in the bladder trigone facilitates urine storage through flattening and lengthening of the bladder base.
The benefits with Betmiga are its ability to reduce the number of daily micturitions and incontinence episodes. The main safety concern relates to cardiovascular safety. Mirabegron at the proposed 50 mg dose shows a modest increment of pulse rate and blood pressure ( 1 bpm and less than 1 mmHg compared with placebo ).
The approved indication is: symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder ( OAB ) syndrome. ( Xagena )
Source: EMA, 2012
XagenaMedicine_2012
