* FDA says journal reprint is misleading
* Materials overstated Taxotere’s benefits -FDA
* Sanofi: materials appropriate, working with FDA (Adds company comment, paragraphs 6-7)
WASHINGTON, May 13 (Reuters) - U.S. health regulators have cited Sanofi-Aventis SA SASY.PA for circulating a reprinted journal article that overstated the benefits of its breast cancer drug Taxotere, according to a letter released on Wednesday.
A copy of an article from the Journal of Clinical Oncology described a study of the drug but is “false or misleading” because it makes unsubstantiated claims about Taxotere’s benefits over rival drug paclitaxel, the U.S. Food and Drug Administration said in an April 16 letter to Sanofi.
Paclitaxel is sold generically by a variety of makers as well as by Bristol-Myers Squibb Co BMY.N under the brand name Taxol.
“These claims misleadingly suggest that Taxotere is superior to paclitaxel in the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and overstate the efficacy of Taxotere. FDA is unaware of substantial evidence to support these claims,” the agency wrote.
The FDA asked Sanofi to immediately stop using the reprint and requested a response from the company by April 30.
Sanofi spokeswoman Lisa Buffington said the company has stopped using materials containing information from the post-marketing study, known as TAX 311. But it believes “the content is appropriate based on current FDA promotion and advertising regulations,” she added.
“We are working with the FDA to determine next steps for addressing the agency’s concerns specified in their letter,” she said in a statement.
The agency posted the letter to its websitehere (Reporting by Susan Heavey; editing by Carol Bishopric, Leslie Gevirtz)
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