Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
|
|
The Wall Street Journal - 6 Mar 1996
Laurie McGinley, Staff Reporter of The Wall Street Journal
The sale of the new Abbott and Merck drugs, members of a class called protease inhibitors, will mark a milestone in AIDS treatment. Though the drugs aren't cures, and may eventually be defeated by the AIDS virus, it appears for the moment that "we have the potential for turning AIDS into a chronic, manageable illness," said Edward Scolnick, president of Merck Research Laboratories, the company's main research arm.
On Friday, a FDA advisory committee recommended approval of Merck's AIDS drug, called Crixivan, known generically as indinavir. FDA Commissioner David Kessler said the agency would clear the drug by the time Merck is ready to ship it. "We don't want to hold up their launch," he said. Dr. Scolnick said that Merck would be ready to begin distributing Crixivan between mid-March and the beginning of April.
The advisory committee's action capped one of the most remarkable weeks in the history of the AIDS epidemic. On Friday, after late-night meetings Thursday between FDA and Abbott officials, the agency approved Norvir, known generically as ritonavir. That approval came just 72 days after Abbott filed its application -- the fastest drug approval in the agency's modern history. And it came just one day after the advisory panel backed its approval.
Norvir was cleared for use alone or in combination with standard drugs, such as AZT, in patients with advanced cases of AIDS. The agency said that the quick action reflected data that showed Norvir roughly cut in half the progression of disease and the rates of death in seriously ill patients. The drug also may be sold for use in healthier patients, but the company must gather more information on the effects on that group.
Norvir can cause nausea, vomiting and other side effects. And it also can pose a danger when taken with certain other drugs; the hazards will have to be spelled out on the label. The FDA approved the first protease inhibitor, Hoffmann-La Roche Inc.'s Invirase, known generically as saquinavir, in December, but the drug is thought to be less potent that the Abbott or Merck versions. Hoffmann-La Roche is a unit of Roche Holding Ltd.
The advisory panel recommended approval of Merck's Crixivan after the company presented studies showing that the AIDS virus fell below levels that could be detected in 40% of the patients that took the drug. The virus declined to below-detectable levels in 90% of the patients who took Crixivan along with AZT and 3TC, another AIDS drug.
Both the Abbott and Merck drugs are expected to carry high price tags, a concern for the AIDS community and policy makers. "We can speed up the process but that doesn't mean everyone will have access to these drugs because not everyone will be able to afford them," Dr. Kessler said.
On Friday, President Clinton asked Congress to approve an additional $52 million for cash-strapped state programs that provide AIDS drugs to the uninsured. Activists hailed the move but said much more will be needed.
960306
WJ960302
Copyright © 1996 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Elton John AIDS Foundation UK, the National Library of Medicine, AIDS Walk of Orange County, and donations from users like you.
Always watch for outdated information. This article first appeared in 1996. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1996. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .