The Chicago Tribune, 435 North Michigan Avenue, Chicago, IL 60611 -- SATURDAY, March 15, 1997 Edition: NORTH SPORTS FINAL Section: BUSINESS Page: 1 Word Count: 435
Chuck Hutchcraft, Tribune Staff Writer.
The FDA approved the use of North Chicago-based Abbott Laboratories' Norvir to treat AIDS-infected children ages 2 to 13. At the same time, it approved the use of Viracept, made by La Jolla, Calif.-based Agouron Pharmaceutical Inc., in the treatment of adults and children.
The action won the applause of the Pediatric AIDS Foundation. "We are pleased that now children, too, may benefit from a protease inhibitor," said Susan DeLaurentis, co-founder of the Santa Monica, Calif.-based group.
But DeLaurentis also expressed disappointment at the fact that the drugs were still not available for infants and at the lag time between the approval of such drugs for adult use and for use in treating children.
"We want drugs tested in kids at the same time as adults if children are going to be using these drugs," DeLaurentis said.
"If we had drugs available to treat babies when they are first diagnosed, we could potentially reverse the infection," DeLaurentis said. "But we are not going to be able to do that until we have these drugs formulated and tested for newborns."
There were 7,296 children in the United States infected with AIDS as of June 1996, the latest figures available from the Centers for Disease Control in Atlanta.
Still, Norvir's approval for children came only a year after its clearance for adults, said Rick Moser, a spokesman for Abbott. It has taken up to four years between the time other drugs have been approved for adult use and when they are cleared for children, he said.
In fact, given the urgency to find medication effective against AIDS, the FDA has greatly accelerated the approval process for protease inhibitors. Agouron's Viracept was approved three months after its application was received.
Norvir and other protease inhibitors, used in combination with each other and with other AIDS drugs, have proven effective against the deadly disease. AIDS researchers now hope it will be possible for AIDS patients to live with their condition to an almost normal lifespan.
Norvir was tested on 44 children by a team of scientists at the HIV and AIDS Malignancy branch of the National Cancer Institute in collaboration with Abbott.
The drug was administered alone for the first 12 weeks, then in combination with other AIDS drugs. Researchers found that children suffered the same side effects as adults taking the drug--nausea, diarrhea, vomiting, asthenia and problems with taste.
Copyright 1997/The Chicago Tribune. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Chicago Tribune, 435 North Michigan Avenue, Chicago, IL 60611.
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