All GLG News Analyses Filed Under: Cardiology

Emerging role of Dronedarone in management of Atrial Fibrillation

March 24, 2009

Analysis by: GLG Expert Contributor

Analysis of:FDA advisory panel approves dronedarone | www.drugs.com

Atrial fibrillation is the most common cardiac rhythm disorder. Amiodarone is effective in maintaining normal rhythm in atrial fibrillation but is associated with potentially serious toxic effects. Dronedarone is a new antiarrhythmic agent pharmacologically related to amiodarone but developed to reduce the risk of side effects. Dronedarone is effective and compared to placebo, rates of side effects on the lungs, thyroid and liver are not significantly increased. In the ATHENA study, recently published in the New England Journal of Medicine (Feb 2009), Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation. In patients with severe heart failure, treatment with dronedarone may be associated with increased early mortality related to the worsening of heart failure.

Remote Monitoring of Cardiac Rhythm Devices Improves

March 19, 2009

Analysis by: GLG Expert Contributor

Analysis of:St. Jude gets approval for updated heart network | www.forbes.com

This represents a significant improvement over the preexisting Merlin system.  Remote monitoring of cardiac rhythm devices is going to become the standard of the industry within the next 5-10 years.  The integration with electronic health records is extremely important and SJM is the leader in this type of integration.

Dronedarone will change medical management of atrial fibrillation

March 19, 2009

Analysis by: GLG Expert Contributor

Analysis of:FDA advisory panel approves dronedarone | www.drugs.com

Dronedarone will likely transform the treatment of atrial fibrillation.  This is the first new drug for atrial fibrillation in a long time that can add substantially to the care of patients.  I suspect it will be a drug that will become one of the most commonly used to treat patients with atrial fibrillation and likely will be a blockbuster drug for this purpose.

Big impact on a big market!

March 13, 2009

Analysis by: GLG Expert Contributor

Analysis of:NEJM Publishes Results From The Landmark ATHENA Trial With Multaq(R) (dronedarone) In Atrial Fibrillation | www.medicalnewstoday.com

Dronedarone has the potential to be a major blockbuster for Sanofi (NYSE:  SNY), given the magnitude of the problem it targets.

Long expected new breakthrough

March 2, 2009

Analysis by: GLG Expert Contributor

Analysis of:NEJM Publishes Results From The Landmark ATHENA Trial With Multaq(R) (dronedarone) In Atrial Fibrillation | www.medicalnewstoday.com

Dronedarone will probably replace amiodarone and maybe some other antiarrhythmics drugs. Unfortunately, the question of its application in heart failyre will have to be answered in the following years

Shadows casted over "to-be" blockbuster drug

March 2, 2009

Analysis by: GLG Expert Contributor

Analysis of:F.D.A. Panel Endorses Lilly Blood Thinner | www.nytimes.com

Prasugrel as a novel drug which was supposed to replace Plavix, especially amid proofs of clopidogrel resistance, interactions with some common drugs such as PPI's, might not do so. Inspite great expectations it might become a potent drug with limited use due to not so acceptable side effect.

Recession Presents Both Challenges And Opportunities For Small MedTech Companies

February 25, 2009

Analysis by: GLG Expert Contributor

Analysis of:Resistant in any recession? US medtech financial update and outlook | www.ey.com

With IPOs virtually eliminated and M&A activity considerably slowed, early stage medtech investors are left with few exit opportunities. Faced with continued uncertainty in the financial markets, investors remain highly selective, leaving many smaller medtech companies strapped for cash. Is this an ideal time for strategic consolidation?

Only a Matter of Time And Only Time Will Tell

February 19, 2009

Analysis by: GLG Expert Contributor

Analysis of:F.D.A. Panel Endorses Lilly Blood Thinner | www.nytimes.com

It's very likely that prasugrel will be approved by the FDA (possibly with restrictions for small persons and for elderly persons). However, whether prasugrel will be adopted by the cardiology community is unclear. While studies have shown that it is more effective than clopidogrel the increased effectiveness also translates into more severe bleeding in the patients taking prasugrel. Because the benefits of prasugrel are not so much bigger than clopidogrel's, and the latter has a better safety profile, clopidogrel will remain the marketleader for a while.

Dronedarone will revolutionize treatment of atrial fibrillation patients

February 18, 2009

Analysis by: GLG Expert Contributor

Analysis of:The ATHENA Trial, New England Journal of Medicine | news.glgroup.com

Dronedarone is the first antiarrhythmic drug that, by whatever mechanism, reduces cardiovascular mortality and improves other important endpoints.  The drug may work in part by controlling rate in atrial fibrillation and by controlling the rhythm. The drug appears safe especially in patients who do not have severe (or acutely decompensated) heart failure and have left ventricular ejection fraction more than 35%.

Prasugrel: Blockbuster or Bust- FDA approval and Usage in Clinical Practice

February 17, 2009

Analysis by: GLG Expert Contributor

Analysis of:F.D.A. Panel Endorses Lilly Blood Thinner | www.nytimes.com

The FDA will follow the recommendation of the advisory panel and approve both the 5 and 10 milligram doses of prasugrel Prasugrel will rapidly become the standard of care in the interventional commnunity in TRITON type patients as well as in non-TRITON type patients with diabetes In the immediate post approval period a switching policy will not be employed- as time goes on switching to plavix at 30 days may become the standard of care Long-term usage of prasugrel may be significantly impacted by the increased incidence and severity of bleeding along with counter-detailing highlighting the limitations of TRITON.

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