Astellas presents positive new mirabegron and enzalutamide data at AUA meeting

Japanese drug major Astellas Pharma (TYO: 4503) as released positive new data on two of its drug candidates, mirabegron and enzalutamide, at the 2015 annual meeting of the American Urological Association (AUA).

Results from its Phase IIIb BESIDE clinical trial demonstrated solifenacin (SOLI; Astellas’ Vesicare brand) with mirabegron (MIRA) as an add-on therapy (ADD-ON) was superior to solifenacin monotherapy in incontinent overactive bladder (OAB) patients. The results of the BESIDE trial showed that the ADD-ON group achieved its primary efficacy endpoints.

In the BESIDE trial, the mean number of daily incontinence episodes was reduced by 1.80 episodes in OAB patients given solifenacin 5mg with mirabegron 50mg (dosage was increased from 25mg after four weeks) as an add-on therapy compared to a reduction of 1.53 episodes seen with SOLI 5mg monotherapy. The difference between the two treatments of approximately 0.26 was statistically significant (P=0.001). The mean number of daily micturitions was reduced by 1.59 micturitions in the ADD-ON group compared to 1.14 micturitions with SOLI 5mg (the difference of 0.45 was statistically significant [P<0.001]).