Hopkins study delays drug's marketing

Nevirapine approved to fight AIDS in adults

March 23, 2002|By Frank D. Roylance | Frank D. Roylance,SUN STAFF

Questions by federal regulators about data gathered during a 1999 Johns Hopkins-led AIDS study in Uganda will mean more than a year's delay for a Connecticut drug-maker that wants to market a drug for the prevention of AIDS infections during childbirth.

The manufacturer, Boehringer-Ingelheim Pharmaceuticals, announced yesterday that it cannot resolve the problems in time to meet deadlines set by the Food and Drug Administration.

"Once the issues are resolved, it is our intention to resubmit the application," said John Wecker, who heads the company's HIV programs in the developing world.

The company's decision will have no practical effect on use of the drug, nevirapine. It has FDA approval for use against the HIV virus in adults. And a U.S. Public Health Service Task Force recommends its use in preventing mother-to-infant transmission.

The manufacturer says the drug is approved for that purpose in more than 60 other countries. Approval by the FDA would simply allow the company to actively market the drug as a way to prevent infections during childbirth.

Investigations by Hopkins and at least five other research teams have found that nevirapine, administered to the mother during labor and to the infant just after birth, can significantly reduce the risk that the baby will be infected.

The findings of the 1999 Hopkins study, authored by Dr. Jay Brooks Jackson and published in The Lancet, are considered "pivotal" to the issue. No one has challenged their validity.

Hopkins spokeswoman Joann Rodgers said yesterday the FDA's review raised issues focusing on the availability of original paperwork from the study; the use of oral, rather than written consent to screen women for participation in the study; and questions about the study's definition of "adverse events."

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