![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Sunday, March 04, 2018 12:38:42 PM
Re Jardiance ....I'll do one of your "Oh my God's"......you are apparently unaware that most ( but not all ) of the diabetics in R-IT would have access to Jardiance since it was approved in most ( but not all ) of the areas R-IT was recruiting in from mid 2014 onwards
eg
Type 2 diabetes: European Commission approves Jardiance® (empagliflozin) tablets for use in adults in Europe
European Commission approves third product from the Boehringer Ingelheim and Lilly Diabetes alliance
RIDGEFIELD, Conn. and INDIANAPOLIS, May 23, 2014 /PRNewswire/ -- The European Commission granted marketing authorization for Jardiance® (empagliflozin) tablets, a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) announced.1
The European Commission approved JARDIANCE 10 and 25 mg once daily tablets for use when diet and exercise alone do not provide adequate glycemic control. JARDIANCE may be used alone when metformin is not considered appropriate due to intolerance, or alongside other glucose-lowering medicines including insulin, when glucose control is inadequate.
--------------------
Kiwi
PS ...belive the CV benefits were discovered / confirmed later in 2016 .......so those prescribing pre 2016 may not have been aware of CV risk reduction .......( doing this quickly so would need to confirm ) by FDA added CV risk reduction later to label
FDA Approves Jardiance to Treat Cardiovascular Disease in Diabetes Patients
Written by Kathleen Doheny
The diabetes drug empagliflozin (Jardiance) is now a ''double duty'' drug. It can be prescribed not only to help treat diabetes, but also to reduce the risk of cardiovascular death in adults diagnosed with both type 2 diabetes and cardiovascular disease.1
Jardiance
The FDA granted approval for this new indication in December, after reviewing a study of 7,000 patients with both conditions. 2 ............( believe this is Dec 2016 ...would need to chk ...drug approved for diabetics mid 2014 )
Doctors call this a major advance for these patients and say it has changed prescribing practices.
PPS
Here it is
FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes
Study links Jardiance to improved survival in patients with type 2 diabetes with cardiovascular disease
For Immediate Release
December 2, 2016
The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.
Recent AMRN News
- Latest Research Highlighting VASCEPA®/VAZKEPA® (icosapent ethyl) REDUCE-IT® Subgroup Data and New Mechanistic Insights into Eicosapentaenoic Acid (EPA) to be Presented at European Society of Cardiology (ESC) Congress • GlobeNewswire Inc. • 08/22/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/05/2024 09:30:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 11:05:34 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 07/31/2024 11:05:26 AM
- Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 07/31/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/29/2024 09:30:08 PM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal • GlobeNewswire Inc. • 07/17/2024 08:15:00 PM
- Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024 • GlobeNewswire Inc. • 07/17/2024 12:00:00 PM
- Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR) • GlobeNewswire Inc. • 07/08/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 11:30:10 AM
- Amarin Board of Directors Announces CEO Transition • GlobeNewswire Inc. • 06/04/2024 11:30:00 AM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A. • GlobeNewswire Inc. • 05/28/2024 12:15:23 PM
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
Maybacks Adds Award Winning Show to Its Lineup Discusses Maybacks Opportunity • AHRO • Aug 22, 2024 11:30 AM
North Bay Resources Announces First Gold Concentrate at Mt. Vernon Gold Mine, Assays 12 oz/ton Gold, 17.5 oz/ton Platinum, and 8 oz./ton Silver, Sierra County, California • NBRI • Aug 22, 2024 10:28 AM
All Things Mobile Analytic, Inc. Reports Major Growth with Over $11 Million in Revenue • ATMH • Aug 22, 2024 7:19 AM
Unitronix Announces Strategic Entry into Cryptocurrency Space • UTRX • Aug 21, 2024 10:00 AM
Mawson Finland Provides Update on Exploration Activities at Rajapalot • MFL • Aug 21, 2024 9:06 AM
Avant Technologies to Implement Robust Cybersecurity Measures for AI-Driven Healthcare Solutions • AVAI • Aug 21, 2024 8:00 AM