GEN Exclusives

More »

GEN News Highlights

More »
Mar 21, 2011

Astellas to Submit Marketing Application for Overactive Bladder Therapy This Year Following Phase III Success

  • Astellas says it expects to file for regulatory approval of the overactive bladder (OAB) therapy mirabegron in the EU and U.S. during the early second part of 2011 on the back of positive data from two Phase III clinical trials. A marketing authorization application for the drug was filed in Japan in June 2010.

    Data from the two reported Phase III studies showed that in comparison with placebo, once-daily mirabegron therapy led to significant improvements in the co-primary endpoints of incontinence episodes per 24 hours, and micturitions per 24 hours. Improvements in both endpoints were also seen after four weeks of treatment, and benefits were observed in terms of volume of urine voided per micturition at the final visit. Astellas points out the Phase III data support those from smaller Phase II dose-finding trials.

    Mirabegron is a beta-3 adrenoceptor (beta3-AR) agonist that acts to facilitate bladder filling and storage of urine, the firm notes. If approved, the drug will complement Astellas’ existing muscarinic antagonist OAB therapy, Vesicare (solifenacin), which was first launched in 2004. The firm reported Vesicare sales of Yen 82.3 billion in fiscal 2009.

    Regulatory clearance of mirabegron would make the drug the first beta-3 adrenoceptor agonist to reach the market, notes Vik Khullar from St. Mary’s Hopsital, Imperial College, London, who acted as principal investigator for the European-Australian Phase III study. “Mirabegron would represent the first oral OAB drug treatment with a completely new mode of action since the launch of oxybutynin several decades ago.”

    “By improving symptoms through its action on beta-3 receptors, mirabegron offers an entirely different approach to existing OAB management,” adds Victor Nitti, M.D., from NYU Langone Medical Center in New York, who was principal investigator for the North American Phase III study. This would represent “good news for the many patients who are unable to achieve the right balance of efficacy and tolerability from current available treatments for OAB.”

     

     


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Companion Animal Care

Do you think Americans spend too much on companion animal care?