Navigation Links
Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe
Date:8/28/2011

TOKYO, Aug. 28, 2011 /PRNewswire/ -- Astellas Pharma Inc. (Tokyo:4503, "Astellas") today announced the submission of a New Drug Application and Market Authorisation Application for mirabegron (generic name / code name: YM178) to the U.S. Food and Drug Administration and the European Medicines Agency. The submissions were sent on August 24 and 26, 2011 (Europe and US, respectively). Astellas is seeking approval for this first in a new class of medicine for the indication of overactive bladder (OAB*) associated with symptoms of urgency, urinary frequency, and urge urinary incontinence.

Mirabegron is a once daily oral selective B3-adrenoceptor agonist discovered and developed by Astellas. The pivotal Phase 3 clinical trials in the U.S. and Europe met primary endpoints compared to placebo.

Astellas has been developing mirabegron as a global project. In Japan, Astellas was granted marketing approval under the trade name of Betanis® tablet in July 2011. Additionally, there is an on-going multiregional Phase 3 study in China, Korea, Taiwan, and India.

Astellas markets the OAB medication solifenacin succinate (known as VESIcare) in **67 countries/areas and has contributed to improving OAB associated symptoms.

*OAB is associated with symptoms such as urinary frequency, urgency, nocturia and urge incontinence.  In the U.S. and Europe, >12% of adults and 30-40% of adults 75 years of age and over are estimated to have some sort of OAB symptoms (Wein AJ, Rovner ES. The overactive bladder: an overview for primary care health providers. Int J Fertil Womens Med. 1999;44:56-66).

** as of July 2011

About VESIcare

INDICATION AND DOSAGE

VESIcare tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended dose of VESIcare is 5 mg once daily. If the 5-mg dose is well tolerated, the dose may be increased to 10 mg once daily.

IMPORTANT SAFETY INFORMATION

VESIcare is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients with hypersensitivity to the product.

Angioedema of the face, lips, tongue and/or larynx have been reported with VESIcare. In some cases angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, VESIcare should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

VESIcare should be administered with caution to patients with bladder outflow obstruction, decreased gastrointestinal motility, controlled narrow-angle glaucoma, or reduced renal or hepatic function. Doses of VESIcare higher than 5 mg are not recommended in patients with severe renal impairment, moderate hepatic impairment, or when administered with ketoconazole or other potent CYP3A4 inhibitors. Use of VESIcare in patients with severe hepatic impairment is not recommended.

In placebo-controlled studies, the most common adverse events reported by patients were dry mouth (10.9%, 27.6%, 4.2%), constipation (5.4%, 13.4%, 2.9%), blurred vision (3.8%, 4.8%, 1.8%), and dyspepsia (1.4%, 3.9%, 1.0%) with VESIcare 5 mg, 10 mg, and placebo, respectively.

The overall rate of serious adverse events was 2%. For the 10-mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction, and one intestinal obstruction). For the 5-mg dose, one case of angioneurotic edema was reported.

For more information on VESIcare, please visit our website at: http://www.astellas.us/docs/vesicare.pdf

http://www.astellas.com/en


'/>"/>
SOURCE Astellas Pharma Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and Co-Commercialize MDV3100 for the Treatment of Prostate Cancer
2. Ironwood and Astellas Announce Japan Licensing Agreement for Linaclotide
3. Emerging Agents from Theravance/Astellas, Johnson & Johnson/Basilea and Forest/Astrazeneca/Takeda Will Drive Modest Growth in the MRSA Drug Market Through 2018
4. Ambit Biosciences and Astellas Enter Strategic Partnership to Research, Develop and Commercialize FLT3 Kinase Inhibitors in Multiple Indications
5. Astellas Announces Full Slate of Independent Director Nominees for Election at OSI Pharmaceuticals 2010 Annual Stockholders Meeting
6. Astellas Announces Successful Completion of Initial Tender Offer for Shares of OSI and Announces Subsequent Offer Period
7. Agensys, an Affiliate of Astellas, Announces Initiation of Phase I Clinical Trial of AGS-16M8F for Renal Cancer
8. Astellas Awards Scholarships to 12 Transplant Recipients and Donors Who Embody Hope, Courage and Achievement
9. Astellas Mobilizes 1,300+ Employees in the Americas to Participate in First Annual Changing Tomorrow Day
10. Although NeurogesX/Astellass Qutenza is Only Approved for Postherpetic Neuralgia, Surveyed U.S. Physicians are Likely to Prescribe It for All Neuropathic Pain Types
11. Astellas Announces Retirement of Donald Rice and Appointment of Sef Kurstjens as CEO and President of Agensys, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 Capricor Therapeutics, Inc. ... biotechnology company focused on the discovery, development and ... enrollment in its ongoing randomized HOPE-Duchenne clinical trial ... of its 24-patient target. Capricor expects the trial ... of 2016, and to report top line data ...
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 ... Tomorrow,s Leaders Scholarship is any indication, the future is ... online at www.diabetesscholars.org by the Diabetes Scholars ... in the way of academic and community service excellence. ... program since 2012, and continues to advocate for people ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital ... area economy by obtaining investment capital for emerging technology companies. SCP has ... have already resulted in more than a million dollars of capital investment for ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Finally, a ... after venous procedures, dermaka cream can be incorporated into the post-surgical treatment plans of ... surgical procedures. , dermaka cream is very effective for bruising and causes a ...
Breaking Medicine News(10 mins):