Boehringer-Ingelheim Pulls Request for FDA Approval to Market Nevirapine to Reduce Vertical HIV Transmission
Drug manufacturer Boehringer-Ingelheim on Wednesday pulled its FDA application for the right to market the drug nevirapine in the United States for the prevention of vertical HIV transmission after FDA regulators said they uncovered problems with a 1999 study performed in Uganda by Johns Hopkins University researchers, the Washington Post reports. The questions relate to procedure and not the validity of the study, which found that use of the drug during childbirth can reduce HIV transmission. News of the FDA's concerns prompted questions on Thursday in South Africa over the drug's safety, but FDA officials said that such fears are "unwarranted" (Vedantam, Washington Post, 3/23). Joann Rodgers, a Hopkins spokesperson, said the FDA's questions centered on the "availability of original paperwork from the study," the use of oral instead of written consent for study participants and the study's definition of "adverse events." John Wecker, head of Boehringer's HIV programs in developing countries, said the company felt it could not assemble the paperwork to respond to the FDA's concerns in time to meet the FDA deadline, but will resubmit the application "[o]nce the issues are resolved" (Roylance, Baltimore Sun, 3/23). However, FDA spokesperson Jason Brodsky said the problems may be "potentially quite serious." He declined to comment further but said the agency was not altering its guidelines for the use of nevirapine (Recer, AP/Milwaukee Journal Sentinel, 3/23).
Nevirapine is approved for use in adults in the United States, and the U.S. Public Health Service Task Force endorses use of the drug to prevent mother-to-child HIV transmission. If approved, Boehringer's application would have permitted the company to market the drug expressly for the purpose of reducing vertical HIV transmission. The Hopkins study, which examined the effects of the drug in 645 mother-infant pairs and was published in the Lancet, was considered "pivotal" to the application (Baltimore Sun, 3/23). Officials from Hopkins and the National Institute of Allergy and Infectious Diseases, the federal agency that funded and oversaw the study, attributed the problems to the study's design. They said the study was intended to be a public health project and, as such, was not designed to meet the "stringent requirements of an FDA submission" (Washington Post, 2/23).