FDA: J&J halted antibiotic study over poor results

[January 07, 2012]  TRENTON, N.J. (AP) -- Johnson and Johnson halted a study of an additional use for its intravenous antibiotic Doribax because data showed pneumonia patients fared better on an older combination drug, according to the Food and Drug Administration.

The FDA said that in a study of patients who developed pneumonia while on a breathing machine, more participants taking Doribax died and fewer were cured than in the comparison group. Those patients were given an intravenous drug, sold by Merck & Co. under the brand Primaxin, that combines the antibiotic imipenem with a second drug that keeps it active in the body longer.

Doribax, which was launched in 2007, remains on the market for two approved uses, infections in the abdomen and in the urinary tract.

Johnson & Johnson, based in New Brunswick, N.J., and its Janssen Pharmaceuticals unit, which makes the injected drug, did not publicly disclose the decision when the study was halted last May. Spokesman Shaun Mickus said Friday that at the time J&J notified the FDA, other health authorities and study investigators about the decision and the interim study results. A more complete data analysis was finished recently, leading to the FDA announcement.

Mickus said the study was ended on the recommendation of an independent monitoring committee. The study was being done to fulfill a requirement of the European Medicines Agency for additional testing after Doribax went on sale, according to Johnson & Johnson. The drug is approved in Europe for pneumonia patients.

J&J has been seeking approval to market Doribax for pneumonia patients in the U.S. since June 2007, but the following year the FDA ruled it could not approve that use without additional data. That decision came after FDA advisers ruled that studies J&J submitted weren't rigorous enough to prove Doribax works as well as older therapies in pneumonia patients.

The FDA said late Thursday that it was reviewing the study results and will release any new information resulting from that investigation later.

The study found that in the group getting Doribax, also called doripenum, about 22 percent of patients died within 28 days and 46 percent were cured. In the comparison group, about 15 percent died within 28 days and 57 percent were cured.

Mickus said Friday the company is still in discussions with the FDA on its application to market Doribax for treating patients who acquire pneumonia while in the hospital. That's a common problem given that hospitalized patients generally are very sick and are exposed to germs more dangerous than those circulating in the community.

J&J has not disclosed annual sales of Doribax. It only reports sales for individual products when they exceed $500 million per year.

Johnson & Johnson shares fell 64 cents to $64.76 in afternoon trading Friday.

The decline also follows media reports late Thursday that a Washington state couple is suing J&J, alleging their 2-year-old son was killed after taking defective Children's Tylenol from a batch that had been recalled.

Johnson & Johnson said in a statement that its 2010 recalls of children's products were not related to the "serious adverse events or cases of overdose" alleged in the lawsuit. The company said it promptly notified consumers, doctors, retailers and regulators about the recall.

[Associated Press; By LINDA A. JOHNSON]

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