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FDA clears Amgen's Corlaner for heart failure

It is the firm’s first cardiovascular product to gain approval

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Amgen's heart failure drug Corlaner has been given the green light by the US FDA, giving the company its first approved cardiovascular product.

The FDA approved Corlaner (ivabradine) after a priority review for reducing the risk of hospitalisation for worsening heart failure in patients with stable, symptomatic chronic heart failure (CHF). 

Specifically patients eligible for treatment with the drug should have left ventricular ejection fraction (LVEF) of no more than 35% - meaning they are at elevated risk of life-threatening arrhythmias and sudden cardiac arrest - but have a normal heart rhythm with a resting rate of 70 beats per minute or more.

Corlaner is already on the market in Europe - where it is sold by privately held Servier as Procoralan and was approved to treat stable angina in 2005 and CHF in 2012. Amgen acquired US rights to the drug in 2013 and analysts have estimated that it could grow quickly into a $500m-a-year product in that market.

More importantly, the approval gives Amgen an opportunity to build its commercial capacity in cardiovascular ahead of the potential future launch of Repatha (evolocumab), its PCSK9 inhibitor for reducing cholesterol which has been tipped to become a blockbuster.

Analysts at GlobalData have said the PCSK9 inhibitor class - which also includes late-stage candidates from Sanofi/Regeneron and Pfizer - could capture a 40% share of the $17.5bn acute coronary syndromes market by 2023.

Corlaner's approval is based on the results of the phase III SHIFT trial, which compared Corlanor to placebo, in addition to standard of care, in more than 6500 patients. Amgen and Servier's drug was shown to reduce deaths and hospital admissions due to heart failure by around 25 per cent compared to placebo.

"Heart failure is a leading cause of death and disability in adults," said Norman Stockbridge director of the FDA's Division of Cardiovascular and Renal Products. 

"Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class," he added.

Amgen indicated that Corlanor functions by inhibiting hyperpolarisation-activated cyclic nucleotide-gated channel that controls the cardiac pacemaker, and is the first new CHF medicine approved by the FDA in nearly a decade.

Meanwhile, market research firm Decision Resources has predicted that growth in sales of CHF treatments in seven countries - the US, UK, France, Germany, Italy, Spain and Japan - will increase the overall value of the market from $2.9bn in 2013 to $8.9bn in 2023.

A large chunk of that increase will come from Novartis' first-in-class dual angiotensin II receptor antagonist/neprilysin inhibitor LCZ-696, but Decision Resources is also predicting a healthy uptick on ivabradine sales on the back of US approval and a roll-out in Japan, where the drug has been licensed to Ono Pharmaceutical. 

Article by
Phil Taylor

16th April 2015

From: Sales

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