UPDATE:Doribax Called Effective For Pneumonia Strain
Wednesday July 16th, 2008 / 23h09
By Jared Favole Of DOW JONES NEWSWIRES Rockville, Md. -(Dow Jones)- Johnson & Johnson's (JNJ) antibiotic Doribax appears effective enough to treat patients with a lethal, hospital-born pneumonia, a panel of medical experts told federal regulators Wednesday. The panel, however, had strong reservations about data Johnson & Johnson presented, saying it questioned the company's methodology for studying the antibiotic, including whether certain patients should have been included in trials. Seven panel members voted to say the drug was effective enough, six voted against that statement. Doribax is already approved to treat complicated urinary tract and intra-abdominal infections. "I voted yes with great reservation," panel member Dr. James K. Stoller said, citing what he called a lack of strength in J&J's studies. Stoller's sentiments echoed statements given by the U.S. Food and Drug Administration, which sponsored the panel meeting and will ultimately decide whether to approve expanding Doribax. Raritan, N.J.-based Johnson & Johnson is seeking FDA approval to expand Doribax to treat pneumonia for patients on mechanical ventilation units. Hospital-born pneumonia, including that transmitted through ventilators, is the third most common cause of healthcare-associated infections and accounted for 35,967 deaths in 2002, according to the FDA. No drug is currently approved specifically to treat pneumonia associated with ventilators. Johnson & Johnson's Ian Friedland, head of the company's clinical development, urged the FDA to approve expanding Doribax, saying there is a medical need for such a therapy. Doctors agree antibiotics, such as Doribax, are extremely effective at treating infections. Biostatistician and vocal panel member Thomas Fleming, who didn't think the drug was effective enough to recommend approval, said the J&J data showed a sign that Doribax increased the risk of death. He said the FDA should consider strengthening the standards it uses to approve antibiotics. He suggested companies should show such an antibiotic lowers the risk of death, rather than just lowering the rates of infection. Shifting standards is a thorny issue for the FDA. The agency held a two-day meeting in early July on whether to raise the standards for approving diabetes drugs. The industry balked, saying such moves would increase costs and ultimately hurt patients by slowing down the development of new drugs. Edward Cox, director of the FDA's antimicrobial products division, said guidance for trial designs from the agency hasn't been updated since 1998. The FDA held today's meeting in light of recent discussions of changing approval standards. John Rex, the panel's industry representative, urged the FDA to continue having meetings and discussions with industry and the medical field about antibiotics and how trials should be designed. "It's absolutely critical that we have a clear regulatory path" for approving antibiotics, he said. Rex is also a vice president at AstraZeneca Plc (AZN). In addition to telling the FDA it should consider requiring antibiotics show they decrease the risk of death before, panel members suggested other measures. Panel member Mark Brantly, a professor of medicine at the University of Florida, suggested the FDA require companies to incorporate CT scans into trials when trying to show if a pneumonia drug is effective. A low-dose CT scan could be used to show whether an antibiotic stops the growth of pneumonia, Brantly said. Cox said the agency will consider the panels' comments when deciding whether to approve expanding Doribax and change its approval guidelines for pneumonia drugs. -By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@dowjones.com Click here to go to Dow Jones NewsPlus, a web front page of today's most important business and market news, analysis and commentary: http://www.djnewsplus.com/al?rnd=tbcz0xXX1Jauzo6mglEnJg%3D%3D. You can use this link on the day this article is published and the following day.
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