Thursday, April 16, 2015

Here's a FDA Post Tax Day drug approval. Is your heart is feeling weak? Do you have CHF?

Corlanor or ivabradine is for chronic heart failure (CHF) due to weakness in the left ventricle in patients whose heart can make 1.167 beats a second (or 70 beats each minute). Beta Blockers are ok to take in combination per the FDA Press release. 

Interestingly the international version of Lexi-Comp says it should be used by those with at least 75 beats a minute. It is also used overseas instead of Beta Blockers in patients with stable angina. Success with unstable angina, and variant angina is not mentioned. Dosages are between 5-15 mg per day depending on how much it lowers the heart rate.

Guide prior to picking it up from your friendly pharmacist.
According to the WSJ there was a study of 6,500 people and it's been approved in Europe since 2012 for CHF and 2005 for angina.

Root cause of the CHF is normally attributed to heart disease or high blood pressure. This strikes about 5 million US citizens. The FDA mentions It was studied in 6,505 people and granted a fast track approval. Look for the Med According to Norman Stockbridge, M.D., Ph.D., who works at the FDA, “Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class.” 

Is the FDA saying slower heart rate is a new mechanism of action / MOA? Beta Blockers bind to beta receptors and slow down the rate... As the body's ability to compress and relax the heart is based on electricity, this medication slows down the speed of electric travel. Yet, lidocaine increases the ventricle's stimulation threshold. Technically no, so it's not more than just decreasing heart rate or decreasing heart rate via an electric pathway. Wait for the newer articles to talk more about the  MOA.

The US manufacturer is Amgen, which got permission to sell it from Les Laboratoires Servier in 2013.



Source: fdalatimes and WSJ

heart
freeimages.com/judith hakze



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