COMPANY DROPS AIDS DRUG PLAN FOR US
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
"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
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.