Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
Reuters NewMedia, Inc. - 8 Nov 1995
Robert Trautman, Reuter
It was the third recommendation the FDA's Antiviral Drugs Advisory Committee made this week for approval of new compounds to treat the virus that causes AIDS. The FDA is not bound by recommendations of its advisory panels but usually follows their advice.
Agency officials gave no indication of how soon it might act on the recommendations, but in the past it has given quick approval for new AIDS drugs. AIDS advocacy groups back approval of all three drugs.
On Wednesday, the panel recommended by a 4-3 vote full FDA approval for the Bristol-Myers Squibb Co. drug stavudine, also known as d4T and Zerit, to treat patients who no longer respond to the long-time AIDS drug AZT.
Conditional FDA approval was given to d4T in June 1994 -- foregoing traditional trials -- under the agency's fast-track procedure used for drugs for life-threatening diseases. Full approval, following further trials of the drug, would allow wider use of the therapy.
Many committee members were hesitant to recommend full approval for d4T on grounds the new trials did not provide enough proof of effectiveness over existing drugs.
On Tuesday, the panel recommended the conditional approval of saquinavir, a new class of drugs that fights AIDS by suppressing the replication of the virus that causes it. It recommended its use in combination with other AIDS drugs but voted against its use as a therapy by itself.
Saquinavir, aimed at AIDS patients with no other treatment options, would be sold by Roche Holding Ltd. under the name Invirase. A "protease inhibitor," it is chemically different from other AIDS drugs. It works to block replication of the human immunodeficiency virus (HIV) by acting on a different stage of the virus' life cycle than other AIDS drugs.
Experts say the AIDS drugs already approved slow the progression of the disease but do not cure it. They also lose their effectiveness after a year or two.
They hope saquinavir can prolong a patient's life or delay the onset of AIDS when the patient has been infected with HIV.
Saquinavir was found to be more effective in combination with the longtime AIDS drug AZT than when taken by itself. The panel Monday recommended conditional approval for the Glaxo Wellcome Plc. drug 3TC for use in combination with the existing drug AZT, also made by Glaxo. 3TC, developed by BioChem Pharma Inc., would be marketed under the name Epivir.
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