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FDA Panel Backs Crestor Expansion by 12-4 Vote

[Crestor would have a serious chance to become the largest-selling drug of all time if not for two bugaboos: i) Lipitor goes generic in the US in 2011; and ii) Crestor itself is under assault by generic challengers (#msg-44505301). #msg-28510348, #msg-33263372, and #msg-28053790—as well as iwfal’s replies to these posts—are good background reads.]

http://www.reuters.com/article/idCNN1521901920091215

›Tue Dec 15, 2009 6:43pm EST
By Lisa Richwine

GAITHERSBURG, Md., Dec 15 (Reuters) - U.S. government advisers on Tuesday backed AstraZeneca's (AZN) bid to promote cholesterol fighter Crestor in a large new market of people with healthy cholesterol levels but other risks [high CRP] for heart disease.

The endorsement moves the company closer to approval of the drug for potentially millions of new patients who are not candidates for a cholesterol medicines under current guidelines.

A Food and Drug Administration advisory committee voted 12-4 that Crestor's benefits of preventing deaths, heart attacks and strokes offset possible risks for certain patients.

"I find the evidence extremely compelling," said Dr. Thomas Wang, a cardiologist at Massachusetts General Hospital.

The FDA will make the final decision but usually follows panel recommendations. One panelist abstained from voting.

The panel reviewed data from a nearly 18,000-patient study called Jupiter, which was funded by AstraZeneca.

The study showed Crestor cut deaths, heart attacks and strokes in middle-aged people with healthy cholesterol but high levels of C-reactive protein (CRP), an indicator of inflammation that is associated with heart disease.

Panelists who backed wider use voiced concern that doctors might use Crestor too broadly in patients at low risk.

"There should be some caution in administering this to those who will clearly benefit," said Dr. Michael Criqui, a cardiologist at the University of California at San Diego.

Wider approval for Crestor would boost sales of the drug, but industry analysts say the size of the opportunity is uncertain because of the looming arrival of generic versions of Pfizer Inc's (PFE) Lipitor in late 2011.

MARKET OF MILLIONS

The FDA said up to 6.5 million Americans meet the criteria used in the Jupiter study. Leerink Swann analyst Seamus Fernandez said that would increase the group of potential patients by about 15 percent.

The panel "appeared to pretty clearly favor the expansion of the treatment pool," which should boost sales of Crestor and statins in general, Fernandez said.

"The key is going to be less the label for this product and more the guidelines" for cholesterol treatment when experts provide initial recommendations expected in the middle of next year, he added.

AstraZeneca Chief Medical Officer Howard Hutchinson said the FDA's 6.5 million estimate was "reasonable" but the group the company hoped to target was "probably smaller than that."

"Our goal is not to be treating very low risk patients," Hutchinson told reporters.

Statins typically are prescribed to lower high cholesterol, a risk factor for heart disease, which remains the leading killer in the United States. But more than half of patients who suffer heart attacks or other cardiovascular problems have normal cholesterol levels. That led AstraZeneca to search for other groups that could benefit from Crestor.

Agency staff asked the advisory panel to weigh higher numbers of diabetes cases, gastrointestinal-related deaths and reports of a "confusional state" in patients who took Crestor instead of a placebo. Panelists generally agreed it was unlikely the deaths and confusion were related to Crestor.

On diabetes, panelists felt the Jupiter findings "probably represent an authentic increase" that may be common to all statins and urged further study, said panel chairman Dr. Kenneth Burman, chief of the endodrine section at Washington Hospital Center.

Crestor's global sales topped $3.6 billion last year. The consensus forecast for 2012 Crestor sales is $6.75 billion, rising to $6.92 billion in 2013, according to Thomson Pharma.

The Jupiter results already have helped boost prescriptions for Crestor since details were unveiled in November last year.

Crestor is a key driver for AstraZeneca as other drugs go off patent, but its exclusivity to 2016 is being challenged by generic manufacturers in a case due to go to trial in February 2010 [#msg-44505301].‹