U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc’s and Schering-Plough Corp’s popular cholesterol drug Vytorin after a study showed it was no better than a generic in preventing the build-up of fatty plaque.
The Food and Drug Administration said it had not yet received a final report on the study, called Enhance. The agency’s review of Vytorin will take about six months after final results are received, the FDA said.
In the meantime, patients with questions about the Enhance study should talk with their doctors, the FDA advised.
“At this time, it is not clear why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to patients treated with simvastatin alone,” an FDA statement said.
Simvastatin is the generic name for Zocor. Vytorin combines Zocor with a newer cholesterol-fighting pill called Zetia.
The FDA review puts an even bigger spotlight on a debate over Vytorin’s value in the wake of the Enhance results early last week and concern over a long delay in releasing the data.
Decline in Vytorin prescriptions
Major medical groups, prominent cardiologists and U.S. lawmakers have weighed in, while prescriptions for the drug have slipped.
“The FDA is attempting to buy time so noise can be filtered out and cooler heads can look at the Vytorin data, but it is unlikely even the FDA will be able to draw clear conclusions,” said Viren Mehta, principal at Mehta Partners, which provides investment advice to the global pharmaceutical and biotechnology industries.
“For a clear picture, we will need to wait for outcomes data (data on heart attack and stroke risk) from larger Vytorin trials” due by 2010 or 2011, Mehta said.
Merck and Schering-Plough sell Vytorin and Zetia in a joint venture, and the products have combined annual sales of about $5 billion.
The Enhance study examined Vytorin against Zocor alone in patients with a rare genetic predisposition to dangerously high cholesterol levels. Vytorin failed to halt the clogging of neck arteries better than Zocor alone, but it did a better job of reducing “bad” LDL cholesterol.
Beyond Vytorin, the FDA said it also would review “whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted.” High LDL is commonly believed to be a major risk factor for heart disease.
FDA officials cautioned the public not to overreact to the Enhance study by turning away from cholesterol-lowering drugs.
Drugs that cut LDL are among the largest selling drugs in the world, and also include Pfizer Inc’s Lipitor and AstraZeneca Plc’s Crestor. Shares of Pfizer and AstraZeneca were also lower after the FDA announcement.
Lipitor, Zocor and other drugs in the same statin class have consistently shown the ability to reduce heart attacks and strokes by up to 30 percent.
Drugmakers criticized for delay
The drugmakers have been criticized by doctors, industry analysts and lawmakers for delaying presentation of results from the trial, which was concluded in 2006, until last week.
“The delay has made everyone uncomfortable,” Mehta said. ”We don’t know why they didn’t come out earlier and just say ... the trial was not showing any possible benefit” in cutting plaque.
Deborah Cohn, a professor of marketing at Touro College Graduate School of Business in New York, said the delay in releasing the results had caused an understandable backlash.
“Consumers feel like there may be something else they’re not telling us,” Cohn said. “Nobody likes feeling like they’re being lied to and that’s how everybody’s reacting.”
Merck spokesman Christopher Garland said the company ”welcomes today’s statement from the FDA as it appropriately communicates information about the Enhance trial as well as information about Vytorin and Zetia.”
A Schering-Plough spokesman could not immediately be reached after the FDA announcement.