Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals announced Friday that it was withdrawing its request that the US Food and Drug Administration approve the drug nevirapine for preventing mother-to-child HIV transmission. John Wecker of Boehringer said the decision came after researchers at the National Institute of Allergy and Infectious Diseases (NIAID) audited a 1999 clinical trial conducted for NIAID in Uganda by Johns Hopkins University researchers. The audit raised questions about the study's supporting documentation, Wecker said, adding that the company will resubmit the application once the issues are resolved.
The 1999 study appeared in the Lancet (354;9181:795). It concluded that nevirapine was more effective than zidovudine in preventing pregnant women from passing HIV to their babies at birth and through nursing. Wecker said the audit uncovered "no reasons to suspect that there was a problem with the fundamental conclusions." However, FDA spokesperson Jason Brodsky said there are problems with the study that "the agency believes are potentially quite serious." Brodsky declined to identify the problems, but said the FDA is not recommending any change in the approved uses of nevirapine. Marketed as Viramune, nevirapine is approved in the United States to treat HIV in adults and children over age two. Nevirapine continues to be used in dozens of other countries by pregnant women and newborns.
Dr. John R. LaMontagne of NIAID said the problems mostly involve differences in record keeping, particularly the FDA's requirement for patients' original records. LaMontagne also said there were "professional differences of opinion" between the Hopkins and Ugandan researchers as to what constitutes a "serious adverse event," each of which must be included in data submitted to the FDA. The drug maker continues to donate nevirapine to programs in some 23 counties to help prevent mother-to-child HIV transmissions.
The FDA requires that data from drug trials, regardless of where they are conducted, meet the same standard. Otherwise, they cannot be used to evaluate a drug for use in the United States, Brodsky said.
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