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WHAT IT MEANS AND WHY IT'S IMPORTANT — The cardiovascular drug market will turn into a difficult conquest in the years to come as it increasingly will be dominated by generics, but that isn’t stopping drug companies from continuing to develop treatments — 299 of them, according to a recent report by the Pharmaceutical Research and Manufacturers of America — for high cholesterol, hypertension, atrial fibrillation, heart failure and other heart-related conditions. Indeed, with around 80 million Americans having cardiovascular disease, according to the American Heart Association, it’s a market that won’t disappear any time soon.
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For a while now, drug industry experts have been playing the funeral dirge for the age of blockbuster drugs — those drugs that reach $1 billion or more in sales per year, often as a result of significant uptake due to their ability to treat widespread disease states. That’s especially true in the cardiovascular drug market, whose star performer, Pfizer’s cholesterol drug Lipitor (atorvastatin), will lose patent protection this year, knocking a hole in the more than $7 billion in annual U.S. sales that IMS Health attributes to the drug.
Nobody can say whether those 299 drugs in development include the next Lipitor, but a lot of them will soon be ready to hit the market. AstraZeneca announced Friday that the Food and Drug Administration hoped to finish its review of Brilinta (ticagrelor), for preventing acute coronary syndrome, by July 20.
A total of 16 regulatory applications seeking approval for new drugs or seeking approval for new uses of old drugs for treating heart disease have been submitted, according to PhRMA’s report. These include Gencaro (bucindolol), ARCA Biopharma’s treatment for genotype-defined heart failure that has received expedited review from the FDA; TAK-491 (azilsartan medoxomil), Takeda’s treatment for hypertension; and rivaroxaban, a drug for preventing stroke in patients with atrial fibrillation, thrombosis and embolism developed by Bayer and Johnson & Johnson. In addition, several drugs have recently finished phase-3 trials, such as GlaxoSmithKline’s Lovaza (omega-3 acid ethyl esters) for atrial fibrillation and a combination of irbesartan with amlodipine developed by Sanofi-Aventis for hypertension.