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FDA approves Repatha for patients unable get to LDL cholesterol under control

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Repatha, a cholesterol lowering drug by Amgen Inc, has been approved by the Food and Drug Administration. This gives birth to a rivalry between Repatha and a similar treatment that got approval just a few weeks back.

Repatha belongs to a new class of drugs that promises to help patients who have not received desired results after using conventional cholesterol medications called statins. Praluent, the first drug of this new category, got approval from the FDA in July. The two pharmaceutical firms manufacturing Praluent are Regeneron Pharmaceuticals and Sanofi SA.

Both patients and doctors were in search of this new class of cholesterol-lowering drugs, which are basically injections to be administered either biweekly or monthly.

Statistics offered by Amgen suggest that around 11 million US residents struggle to lower their LDL or bad cholesterol to a healthy level using statins such as Crestor and Lipitor.

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Sean Harmer, the head of Amgen’s research and development, said that approval of drugs belonging to this new class will benefit many patients who are finding it difficult to get to a normal LDL level using statin pills.

However, drug benefits managers and insurers have expressed serious concerns. According to them, these drugs are extremely costly. Amgen informed that people using Repatha will need to spend $14,100 per year. Praluent, on the other hand, requires patients to spend a whopping $14,600 a year. Analysts are saying that drugs belonging to this new class will eventually perform annual sales of almost $10 billion worldwide.

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FDA approved Praluent for being taken in conjunction with statins for patients with familial hypercholesterolemia, a hereditary disorder, or for people suffering from coronary artery disease that demands additional reduction of cholesterol. The approval conditions for Repatha have been kept unchanged by the FDA.

The newly-established rivalry between the two drugs of the new class has given drug benefit managers and insurers the opportunity of negotiating discounts. A spokesperson of the Express Scripts Holding Co. said that his company is planning to leverage this rivalry for achieving the best possible drug price for payers and patients represented by the company.

Such competitions used to be pretty unusual earlier. Previously, the company launching a new drug onto the market first used to enjoy a substantial benefit.

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SOURCEFDA
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An entrepreneur by birth, blogger by choice, and geek by heart. He founded Sprouts Media, a blogs/websites network company, currently owns over 10 popular web properties, to cater his passion of journalism and entrepreneurship. He is also known as an avid reader, technology enthusiast, explorer, and a broken lover. His passion for knowledge keeps him running all the time. A pure vegetarian, who believes in reincarnation & law of karma and follows the philosophy of “Live and let others Live” because all living beings have equal right on the resources of this planet. He loves to write about Technology and Social Issues on his blogs. He can be reached at nitin [at] sprouts.media.