FDA Approves Amgen's Corlanor Drug For Heart Failure

Amgen (AMGN) closed the trading day at $165.47, up 1.78% as the company announced today that the FDA had approved a heart-failure drug known as Corlanor -- ivabradine. The drug Corlanor is an all oral type drug that is intended to reduce hospitalization from worsening heart failure. The use of the drug is for patients who have stable chronic heart failure, patients who are in sinus rhythm with a resting heart rate of greater than or equal to 70 beats per minute, and maximum tolerated doses of beta blockers. In essence the drug is specifically built to inhibit the heart rate from becoming unstable.

Corlanor is a great drug for these hospitalized chronic heart failure patients because of a few reasons, the first being that the efficacy shown in trials was so great that the FDA designated the drug compound for a priority review. The FDA priority review program is specifically in place to expedite approvals for drugs that fit an unmet medical need. Considering Corlanor is the first heart-failure drug to be approved in about 12 years, that is probably one of the reasons why the FDA gave it a priority review.

According to Amgen, heart failure costs an estimated $31 billion in the U.S. each year. A lot of the cost comes from these patients having to be hospitalized so often, an endless cycle of hospital visits. Corlanor is designed to keep the heart more stable thereby decreasing the amount of hospital visits a patient needs. Amgen proved the efficacy of Corlanor in a large study with 6,500 patients known as the "SHIFT" study. This trial was a phase 3 trial which either gave these patients Corlanor or a placebo compound on top of standard of care therapies like beta-blockers.

The phase 3 SHIFT trial showed that Corlanor significantly reduced the risk of primary composite endpoint of hospitalization or cardiovascular death for worsening heart failure. That is a huge positive for these patients who haven't seen a new drug approved for their condition in so many years. The adverse effects of Corlanor were not bad either and they were comparable to the placebo compound within the clinical trial. The main adverse events were: bradycardia (heart beats slower than normal), hypertension, or increased blood pressure.

Chronic heart failure affects approximately 5.7 million people in the U.S. with about half of those people suffering from reduced left ventricular function of the heart. Amgen is already up and running to start selling its newly approved Corlanor drug; in fact, Amgen expects the drug to be available to doctors and patients alike within a week. The European Medicines Agency -- EMA -- had already approved Corlanor back in 2012 for heart failure. Prior to the 2012 heart failure approval, Corlanor was also approved to treat stable angina in 2005 by the EMA. Going forward, Amgen seems to be set in the cardiovascular space and should generate a large amount of revenue in the foreseeable future targeting this large cardiovascular market.