Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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The Wall Street Journal - 1 Mar 1996
Laurie McGinley, Staff Reporter of The Wall Street Journal
Last night, top officials of the Food and Drug Administration were meeting with officials of Abbott Laboratories in an effort to clear the way for swift approval of the company's new AIDS drug, Norvir, for patients with advanced cases of AIDS. Approval could come as soon as today, according to industry officials, though they emphasized that the timing isn't assured. If approval does occur today, it would be one of the fastest, if not the fastest, drug approval in the modern history of the FDA.
Norvir is one of a new class of AIDS drugs called protease inhibitors because they disable protease, an enzyme critical to the replication of HIV, the virus that causes AIDS, or acquired immune deficiency syndrome. Studies presented by Abbott about a month ago showed that the drug prolongs life and delays progression of the disease in seriously ill patients.
Last night's meetings occurred after an FDA advisory committee recommended approval of Norvir, known generically as ritonavir, for the sickest AIDS patients. The panel gave only a conditional nod to use of the drug for patients in earlier stages of the disease. It recommended that the FDA require additional studies on the effect of the drug on that group before granting full approval for that use, although the company could sell the drug for that use once the trial began.
The first protease inhibitor, Hoffmann-LaRoche's Invirase, was approved by the FDA in December, but the Abbott drug and Merck & Co.'s Crixivan are both more powerful and have been anxiously awaited by AIDS patients.
Though they aren't cures for AIDS, and eventually may be thwarted by the human immune deficiency virus, or HIV's uncanny ability to develop resistance to new therapies, the drugs are more effective in taming the virus than anything now available, especially when used with traditional drugs called nucleoside analogs.
The advisory panel is expected today to approve Merck's Crixivan, which is known generically as indinavir, adding fuel to the already furious competition to get the protease inhibitors to market. At the moment, Abbott has the edge over Merck because it submitted its application in December, a month before Merck.
Last night, David Kessler, an FDA commissioner, said that the agency this week completed the necessary inspections of the Abbott plants that will produce Norvir.
Hemant Shah, an independent drug analyst, estimated that sales of Crixivan and Norvir would reach $100 million to $200 million a year each, but other analysts say that sales could be much higher. In addition, two other protease-blocking drugs may be approved next year.
Abbott officials said the drug would be available in pharmacies within two weeks of an FDA approval.
One potential problem with the protease inhibitors is cost. The Abbott drug hasn't been priced yet, but Invirase, which is known generically as saquinavir, costs about $7,000 a year. Moreover, the most effective treatments, studies show, involve combining new and existing drugs, which could easily push up the price of AIDS drug therapy to $12,000 or $15,000 year. Already, some AIDS advocates are talking quietly about strategies to force the drug companies to lower their prices.
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