FDA actions may signal tougher rules
Agency rejects 2 cholesterol drugs
WASHINGTON - Regulators ended last week and started this one by rejecting two potential blockbuster cholesterol drugs, leaving three drug makers reeling and Wall Street wondering if tougher approval standards are here.
Merck surprised investors late Monday when it said the Food and Drug Administration did not approve its cholesterol pill Cordaptive. The company was counting on the approval to help replace flagging sales of its older cholesterol drugs, Vytorin and Zocor.
The agency dealt a similar blow to Genzyme Corp. and Isis Pharmaceuticals Friday, saying the companies must conduct additional studies of their cholesterol drug, mipomersen.
Yesterday, shares of Merck & Co. fell just over 10 percent while Isis fell nearly 4 percent. And analysts saw the FDA's back-to-back refusals as a potential signal of a more worrisome trend: tougher approval standards for cholesterol drugs. The already-crowded market for the pills was the largest in the United States last year, with total sales of $18.4 billion, according to IMS Health.
WBB Securities analyst Steve Brozak said the FDA has increasingly rejected drugs that don't offer a clear advantage over older medications.
The FDA demanded more data from Wyeth four times before approving its antidepressant Pristiq, a follow-up to an older drug, Effexor. And last year, regulators flatly rejected potential blockbusters to treat obesity and arthritis from Sanofi-Aventis and Merck.
The FDA's unexpected rejections come amid a debate over the benefits of newer cholesterol drugs, triggered by a failed study of Merck and Schering Plough's blockbuster Vytorin. The drug, which had 2007 sales of $5 billion, combines Merck's older cholesterol-lowering drug Zocor with Schering's Zetia.
Results released by the companies in January showed that while the combination did lower cholesterol levels, it was no better at reducing fatty plaque than Zocor alone, which is now available as a low-cost generic. Experts called on doctors to return to the older, more established class of cholesterol-lowering drugs known as statins, which includes Zocor and Pfizer's Lipitor.
And lawmakers questioned whether the FDA's "lower is better" criterion for approving cholesterol drugs should be reexamined. The FDA has long approved drugs based on their ability to lower bad cholesterol, which is believed to reduce risk of heart attack and death.
But the Vytorin results suggest the connection between higher cholesterol and negative outcomes may not be as concrete as initially thought.
While agency staff have said they are not changing the standards for approving cholesterol drugs, analysts say their actions suggest a shift.
Genzyme and Isis on Friday said the FDA would not grant their drug broad approval based solely on lower cholesterol levels. Instead, the companies said they will have to conduct a large-scale study tracking whether patients actually live longer or have fewer heart problems while taking their drug.
Cowen and Co. analyst Eric Schmidt said that while the FDA officially hasn't revised its guidelines, "changes appear to be happening behind the scenes before they're announced in the open." 