Reuters 22 March 2002

Washington -- A company that makes a key drug used to fight the AIDS virus said on Friday it was dropping plans to try to get permission to widen marketing of the drug in the United States after irregularities were found in African trials of the drug.

Nevirapine has been found to reduce the risk that a mother infected with HIV would pass on the virus to her baby during or soon after birth. Only small doses of the drug are needed to protect the baby. German drugmaker Boehringer Ingelheim, a privately held company, had hoped to apply to market the drug in the United States for this use. Sold under the name Viramune, it is already widely prescribed for adults, and doctors are free to prescribe the drug any way they wish.

But Food and Drug Administration (FDA) approval is needed for the company to actively promote the drug for use in preventing mother-to-child transmission in the United States. When scientists started going through the data from the 1999 trial done in Uganda on nevirapine, some problems were found, Boehringer and the National Institute for Allergies and Infectious Diseases (NIAID) said in separate statements.

"Boehringer Ingelheim is aware that questions have been raised regarding reporting and documentation in a study conducted in Uganda for prevention of the transmission of HIV from mother-to-child during birth called HIVNET 012," the company said in a statement.

"Although no evidence has been found that the conclusions of HIVNET 012 (the Uganda trial) are invalid or that any trial participants were placed at an increased risk of harm, certain aspects of the collection of the primary data may not conform to FDA regulatory requirements," the NIAID, which helped sponsor the trial, said in its own statement.

"A comprehensive effort to access the primary data has begun to determine the applicability of the data collection processes to these regulatory requirements."

Officials at NIAID and Boehringer were not immediately available for comment. "Since this NIAID and Boehringer Ingelheim review could not be completed within the remaining timeline for FDA action for the supplement, Boehringer Ingelheim has notified the FDA of its decision to withdraw the U.S. supplemental New Drug Application for prevention of mother-to-child transmission at this time," Boehringer said.