Navigation Links
Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes
Date:12/12/2012

RARITAN, N.J., Dec. 12, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes.

Canagliflozin is an investigational, oral medication for the treatment of adult patients with type 2 diabetes. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to people without diabetes, which may contribute to elevated glucose levels. Canagliflozin, a selective sodium glucose co-transporter 2 (SGLT2) inhibitor, blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

Metformin is a first-line pharmacotherapy that can be used alone or with other medications, including insulin, to treat type 2 diabetes. In people with type 2 diabetes, the liver overproduces glucose, which increases blood glucose levels. Metformin lowers blood glucose levels by decreasing the amount of glucose made by the liver.

If approved, this canagliflozin/metformin fixed-dose combination therapy could provide convenience for patients who may benefit from two diabetes medications working in one pill.

A significant portion of the clinical data in this NDA are derived from the comprehensive global Phase 3 clinical development program for canagliflozin, which were included in the NDA submitted to the FDA on May 31, 2012. The canagliflozin Phase 3 program represents the largest late-stage development program for an investigational pharmacologic product for the treatment of patients with type 2 diabetes submitted to health authorities to date.

The Phase 3 program evaluated the safety and efficacy of canagliflozin across the sp
'/>"/>

SOURCE Janssen Research & Development, LLC
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Janssen Research & Development Submits XARELTO® (rivaroxaban) to U.S. FDA for the Treatment and Prevention of Recurrent Venous Thromboembolism
2. Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin to Treat Patients with Type 2 Diabetes
3. Janssen Announces Initiation Of Phase 3 Development Program For Sirukumab In Rheumatoid Arthritis
4. Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab
5. West Announces Agreement with Janssen Biotech to Develop and Commercialize a New Self-injection Technology
6. Janssen Announces Collaboration with Vertex on Phase 2 Study to Investigate an All-Oral Regimen of Simeprevir (TMC435) and VX-135 for Treatment of Hepatitis C
7. Janssen and Johnson & Johnson to Provide Webcast Presentation of Immunology Pivotal Phase 3 Data Being Presented at the American College of Rheumatology Annual Meeting
8. Efficacy and Safety Data from Phase 2B Trials of Janssens Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual Meeting of the American Association for the Study of Liver Diseases
9. Janssen Research & Development Announces Establishment of Global Cross-Pharmaceutical Clinical Trial Investigator Databank
10. Army Researcher Develops Potential Vaccine Carrier That May Give Stockpiling Efforts A Shot In The Arm
11. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/18/2014)...  In a policy paper released ... largest lesbian, gay, bisexual and transgender (LGBT) civil ... for Pre-Exposure Prophylaxis (PrEP). PrEP is any medical ... spread of a disease or infection prior to ... drug combination currently approved for PrEP, which protects ...
(Date:10/17/2014)...  Amgen (NASDAQ: AMGN ) today announced ... president of Gladstone Institutes and Gladstone,s Robert W. and ... are pleased to welcome Dr. Sandy Williams ... , chairman and chief executive officer of Amgen. "Dr. ... his direct experience in our industry will both be ...
(Date:10/17/2014)... 2014 According to ... Technique (Optical Coherence Tomography, Hyperspectral Imaging, Photoacoustic ... Neurology, Oncology, Cardiology) - Global Forecasts to ... Optical Imaging market over the forecast period ... $917.1 million in 2014 and is expected ...
Breaking Medicine Technology:HRC Endorses PrEP, Calls for Bold Action to Expand Access to Anti-HIV Drug 2HRC Endorses PrEP, Calls for Bold Action to Expand Access to Anti-HIV Drug 3Amgen Announces Appointment Of R. Sanders Williams To Board Of Directors 2Amgen Announces Appointment Of R. Sanders Williams To Board Of Directors 3Optical Imaging Market Worth $1,669.2 Million by 2019 2Optical Imaging Market Worth $1,669.2 Million by 2019 3Optical Imaging Market Worth $1,669.2 Million by 2019 4
(Date:10/20/2014)... October 20, 2014 ASCNYC (ascnyc.org) ... that helps New Yorkers living with HIV/AIDS and ... health, housing, recovery and self-sufficiency. Each year, ASCNYC ... local community through their tireless efforts. , ... Shapses , has been selected as this year’s ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Zereana Jess-Huff, a ... Mrs. Maryland 2014 on a platform to think outside the ... and uses her position to raise awareness about women’s other ... for breast cancer. You say the color pink and everybody ... know for a fact that it has not been won ...
(Date:10/20/2014)... CA (PRWEB) October 20, 2014 AttorneyOne.com, a ... the latest information from the FDA on Sit and ... October 10 not to purchase or use Sit and Slim ... and Slim II is promoted as weight loss product on ... removed from the market in 2010 for safety reasons, can ...
(Date:10/20/2014)... October 20, 2014 Based on ... the only imaging assays capable of determining DNA ... test.  With these three dimensions of high-resolution data, ... detect the widest range of disease-causing genetic rearrangements, ... by other genomic tools, including today’s advanced sequencing ...
(Date:10/20/2014)... DALLAS (PRWEB) October 20, 2014 It’s hard ... for many orphans and vulnerable children around the world, it’s ... by some people, many children are forced to walk barefoot ... for their families or play with their friends. , ... partnering with Air1 Radio in October to encourage ...
Breaking Medicine News(10 mins):Health News:Savills Studley's Marc Shapses To Be Honored as 2014 "Positive Changemaker" by ASCNYC 2Health News:Savills Studley's Marc Shapses To Be Honored as 2014 "Positive Changemaker" by ASCNYC 3Health News:Ovarian Cancer Survivor Mrs. Maryland Urges Media to Think Outside the Bra 2Health News:Ovarian Cancer Survivor Mrs. Maryland Urges Media to Think Outside the Bra 3Health News:FDA Advises Not to Use Sit and Slim II: AttorneyOne Monitors and Keeps Consumers Informed 2Health News:KromaTiD Launches Genome Screening and Discovery Services 2Health News:KromaTiD Launches Genome Screening and Discovery Services 3Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 2Health News:Buckner Shoes for Orphan Souls® Garners Support from Air1 Radio 3
... A new report released Wednesday,February 11, 2009 by ... physical activity, Special Olympics athletes are more physically active,than ... , U.S. Vice President Joe ... Winter Games in Boise, Idaho on Thursday, February 12, ...
... Virtua Health has responded to the public regarding legal action ... Court judge ordered Virtua to stop its Top Doc advertising ... advertising statements are fraudulent. Cooper also sent an e-mail to ... "Virtua has always had the highest ethical standards and ...
... , ... Eagan, MN (Vocus) February 11, 2009 -- Employees of DeCare ... Northeastern Minnesota. A company cookbook was created and recipes were gathered ... than 200 cookbooks were sold. , , , , ,"After years ...
... Feb. 11 Cogdell Spencer Inc. (NYSE:, CSA ... of the Northwest,Region for the Company,s wholly owned subsidiary, ... Based in the Company,s Seattle office, Mr. Aigner ... be responsible for all,design-build and development projects in the ...
... with salivary gland , , WEDNESDAY, Feb. 11 (HealthDay News) -- A ... who blew his tuba so hard that he sent air into ... the condition after the boy developed swelling and pain around his ... Deepa Mukundan, who wrote about the case in the Feb. 12 ...
... ("Transition" or the "Company") (TSX: TTH; NASDAQ: ... disease indications with large markets, today announced its financial ... Selected Highlights, -------------------, ... and up to the date of this press,release, the ...
Cached Medicine News:Health News:Special Olympics Issues Report on the Impact of Special Olympics Healthy Athletes Initiative to show Need for Reauthorization of the Special Olympics Sport and Empowerment Act of 2004 2Health News:Special Olympics Issues Report on the Impact of Special Olympics Healthy Athletes Initiative to show Need for Reauthorization of the Special Olympics Sport and Empowerment Act of 2004 3Health News:Virtua Health Responds to Court Order 2Health News:Company Cookbook Proceeds to Benefit United Way of Northeastern Minnesota 2Health News:Cogdell Spencer Announces Aigner as President in the Northwest Region 2Health News:Cogdell Spencer Announces Aigner as President in the Northwest Region 3Health News:Tuba Spells Trouble for Young Musician 2Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 2Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 3Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 4Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 5Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 6Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 7Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 8Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 9Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 10Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 11Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 12Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 13Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 14Health News:Transition Therapeutics Announces Second Quarter Fiscal 2009 Financial Results 15
Gentle curve facilitates less traumatic removal from eye. Increased length ideal for myopic eyes...
... Tip flattened and angled 90 1.0mm from end, ... lock high pressure extension tubing set, Capable of ... OD- 1.5mm (.06 in) long luer lock, high ... tubing. Bend 1.0mm from end. (Cannulas ...
Rounded tip for even incisions reducing post-op astigmatism...
Stab incision blades color coded for simple and accurate identification...
Medicine Products: