Crestor gains FDA approval to treat atherosclerosis

WILMINGTON, Del. —AstraZeneca’s drug Crestor has joined the elite ranks of cholesterol-fighting agents that also have been indicated to fight atherosclerosis.

The Food and Drug Administration recently approved Crestor as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. An enzyme blocker in the statin class, Crestor is used along with a proper diet to help lower triglycerides and cholesterol in the blood. Atherosclerosis is the progressive buildup of plaque in the inner walls of the arteries that occurs as a result of elevated cholesterol, and presents no visible symptoms.

“This new indication allows us to share what we’ve learned in clinical trials: That even in people with low Framingham risk scores or low risk of cardiovascular disease and early signs of atherosclerosis, the disease progresses if untreated,” said Mike Tilton, AstraZeneca’s vice president of cardiovascular primary care. “In the METEOR trial, patients with hyperlipidemia who took Crestor overall experienced no significant progression of atherosclerosis.”

METEOR—Measuring Effects on intima-media Thickness: an Evaluation Of Rosuvastatin—measured the effects of Crestor on plaque buildup in the arteries using carotid intima-media thickness, which is an early sign of atherosclerosis.

The trial, in which patients took Crestor 40 mg, demonstrated a slowing of progression of atherosclerosis in people with early signs of the disease, elevated LDL or bad cholesterol and low cardiovascular risk. The results of the METEOR trial were the main reason AstraZeneca asked the FDA to add this treatment to its labeling.

The FDA’s expanded approval of Crestor to fight the condition could give the product a significant boost. It joins a small but growing list of statins—including Lescol, Mevacor and Pravachol—containing language in their labels regarding slowing the progression of atherosclerosis, according to the FDA.

Another product, Niaspan—which is used to lower cholesterol and triglycerides in the blood—has language for slowing the progression and promoting the regression of atherosclerosis, in combination with a resin that binds to bile acid.

The FDA also stated that some of the drugs not approved to treat atherosclerosis were Lipitor, Zetia, Vytorin and Advicor. However, the agency noted, “A lot of this is semantics. Most of the statins have outcomes data demonstrating that their drug reduces the risk for a heart attack, angioplasty, etc. The indication may not say that the drug is indicated to treat atherosclerosis per se, but that is what is being treated regardless of the language for the indication.”

While it’s a big step for AstraZeneca to have another treatment option for its third-best-selling drug, other recent efforts by the company may have a bigger impact on future sale results for Crestor. Last month, AstraZeneca announced that it had filed patent-infringement actions in the United States against nine generic drug makers, all of which had submitted plans to sell me-too versions of Crestor. Cobalt Pharmaceuticals was the first company to announce its filing of an application to manufacture a generic version of Crestor in early November 2007. Since then, AstraZeneca has received similar patent challenges from eight additional generic drug makers.

All of them plan to market a cheaper generic form of Crestor in the key U.S. market before patents protecting the medicine expire.

Crestor, which had sales in the United States of $2 billion for 2006, is covered by three key patents valid until 2016, 2020 and 2021. But the generic firms claim they have either found a way not to infringe these patents—or that the patents themselves are invalid or unenforceable. AstraZeneca said challenges had come from Teva Pharmaceuticals, Auro-bindo Pharma, Apotex, Par Pharmaceuticals, Novartis, Sandoz, Mylan, Glenmark Pharmaceuticals and Sun Pharmaceuticals. Novartis and Glenmark are the only companies, as of yet, not involved in the patent-infringement cases by AstraZeneca.

The only positive for the company following all these patent challenges is that, if the companies launch their product before the court case is settled and if AstraZeneca wins, the branded drug maker would be entitled to a huge settlement to compensate for the amount it lost by the launch of a generic.