Astellas has presented promising late-stage data on its investigational overactive bladder treatment mirabegron and filings are planned for the USA and Europe later this year.
Data from two Phase III trials (one in Europe/Australia and the other in North America) were presented at the European Association of Urology conference in Vienna, Austria. They showed that after 12 weeks, once-daily mirabegron therapy led to significant improvements in the co-primary endpoints of incontinence episodes and micturitions each 24 hours compared to placebo. The new data confirm findings from smaller Phase II studies in which significant improvements were seen in a broad range.g of OAB symptoms, the company noted.
Mirabegron is a beta-3 adrenoceptor agonist that facilitates bladder filling and storage of urine, said Astellas, which already markets an OAB treatment, Vesicare (solifenacin). The Tokyo-headquartered drugmaker quoted Vik Khullar from St Mary’s Hospital, Imperial College, London and principal investigator for the European-Australian Phase III study, as saying that the findings are very exciting and “mirabegron would represent the first oral OAB drug treatment with a completely new mode of action since the launch of oxybutynin several decades ago".
Mr Khullar added that unlike antimuscarinics, mirabegron works by improving the storage capacity of the bladder and would provide "an effective new treatment option for OAB patients who continue to suffer from the distressing symptoms of incontinence and frequent need to pass urine". A marketing authorisation application has already been filed for the drug in Japan, in June last year.