Red Bridge Card Driver

Mirabegron, new drug

in development for bladder

overactive

The results of two phase III trials presented at the Congress of the European Association of Urology, showing improving significantly urinary incontinence and urinary frequency.

Mirabegron, the first of a new class of compounds in development for the treatment of overactive bladder, has been shown in two phase III clinical trials to significantly improve key symptoms of disease: urinary incontinence and frequency of urination. For the first time, Astellas Pharma presented these results at the XXVI Annual Congress of the European Association of Urology held in Vienna.

After 12 weeks of treatment with once daily mirabegron, there was a significant improvement compared to baseline in the two co-primary endpoints: incontinence episodes in 24 hours and number voiding in 24 hours, compared with the placebo group. Also seen significant improvements in key secondary endpoints: incontinence episodes in 24 hours and number of voids in 24 hours in the fourth week of treatment and the volume voiding of urine at the final visit. In both studies, mirabegron was well tolerated with low side effects.

"The findings of these studies are very encouraging. Mirabegron could represent the first oral drug treatment for overactive bladder with an entirely new mechanism of action from the marketing of oxybutynin for decades and, if approved, would represent the first agonist beta-3 adrenergic receptors to market " says Dr. Vik Khullar, St. Mary's Hospital at Imperial College London and lead investigator of the European-Australian Phase III.

The researcher added that, "unlike the antimuscarinics, mirabegron works by enhancing the storage capacity of the bladder. As noted in these two studies, the drug may provide an alternative and effective new treatment for OAB patients who continue to experience bothersome symptoms of incontinence and frequent urination. "

Mirabegron is a potent and selective agonist of beta adrenergic receptor-3 (β3-AR) that activates muscle β3-AR detrusor of the bladder for easy filling and urine storage. It was developed by Astellas, whose drug solifenacin (Vesicare) is currently one of the most widely used treatments for overactive bladder.

"Vesicare has provided health benefits for people with OAB around the world since it was first marketed in 2004, while mirabegron, with a different mode of action, Vesicare complements and is an important addition to our portfolio of urology drugs, "says Masafumi Nogimori, president and CEO of Astellas Pharma Inc.

New data from phase III trials confirm and corroborate the findings of dose-finding studies in phase II and smaller, in which significant improvement was observed in a wide range of symptoms of OAB, including incontinence episodes and frequency of micción.6, 7

"By improving the symptoms through its action on beta-3 receptors, mirabegron offers a completely different approach to the existing treatment of OAB and this may be good news for the large number of patients who fail to achieve the right balance of efficacy and tolerability to currently available treatments for OAB, "says Dr. Victor Nitti, the NYU Langone Medical Center in New York, USA. UU., And principal investigator in phase III U.S. trial.

Astellas submitted a marketing authorization application for mirabegron in Japan in June 2010 and plans to submit to the FDA and the EMA from July to September 2011.

JANO.es · April 4