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Amarin's Vascepa Gets ADA Recommendation For Patients With Diabetes And High Triglycerides

 
• By Mandy Jackson

The company has racked up a lot of wins for its proprietary fish oil derivative based on the REDUCE-IT study, the latest being inclusion in diabetes treatment guidelines. Amarin also has now submitted a supplemental NDA seeking a label update reflecting the outcomes trial results.

Stethoscope and small red heart on color background. Heart attack concept - Image

Amarin Corp. PLC won its first big recommendation from a physician group for the use of Vascepa with inclusion of its proprietary fish oil derivative in American Diabetes Association (ADA) guidelines for the treatment of diabetes patients with atherosclerotic cardiovascular disease (ASCVD).

The March 27 ADA announcement was followed by Amarin's own news on March 28 that it has now completed a planned supplemental new drug application (sNDA) submission to the US FDA seeking a label update based on the REDUCE-IT cardiovascular outcomes trial

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Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By Kevin Grogan

As CEO Anderson backs high prices for innovative drugs in Europe

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Copycats Compound Novo’s Wegovy Growth Problems

 
• By Andrew McConaghie

The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.

Merck & Co. CMO Eliav Barr Assures On Pipeline As Keytruda LOE Looms Large

 
• By Jessica Merrill

Chief medical officer Eliav Barr, responsible for overseeing clinical development, talked to Scrip in an interview at Merck’s headquarters about the company’s pipeline diversification.

More from Therapy Areas

iTeos/GSK To Terminate Collaboration After TIGIT Trials Flop

 
• By Alaric DeArment

Belrestotug is the latest anti-TIGIT candidate to fail to meet expectations. iTeos said it will pursue strategic alternatives.

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 
• By Andrew McConaghie

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By Kevin Grogan

As CEO Anderson backs high prices for innovative drugs in Europe