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. - 7 Nov 1995
Robert Trautman, Reuter
AIDS advocacy groups have urged quick Food and Drug Administration approval of the Roche Holding AG drug saquinavir for people who have no other treatment options.
Saquinavir is one of two new AIDS drugs being considered this week by the Antiviral Drugs Advisory Committee, which advises the FDA on the safety and effectiveness of new drugs.
On Monday, the panel recommended the FDA give conditional approval to the Glaxo Wellcome Plc. drug 3TC for use in combination with the existing drug AZT, also made by Glaxo.
The panel made its recommendation after reviewing trials that showed patients treated with both AZT and 3TC had significantly increased numbers of infection-fighting CD-4 cells and reduced levels of HIV virus.
Conditional approval requires additional drug trials before full FDA approval is granted. The FDA is not bound by the recommendations of its advisory committees but usually accepts them.
3TC, developed by BioChem Pharma Inc., would be marketed under the name Epivir.
The new class of drugs being reviewed for conditional approval is a "protease inhibitor" and is chemically different from existing AIDS drugs. It works to block the replication of the human immunodeficiency virus (HIV) that causes AIDS by acting on a different stage of the HIV life cycle than other AIDS drugs.
Experts say the already approved AIDS drugs slow the progression of AIDS but do not cure it. They also lose their effectiveness after a year or two.
They hope that saquinavir can prolong an AIDS patient's life or delay the onset of AIDS when the patient has been infected with HIV.
The FDA's accelerated review process is for drugs to treat life-threatening diseases for which there are no other treatments.
On Wednesday, the panel is to review trials of the drug stavudine, known as Zerit and d4T, which the FDA gave accelerated approval for experimental use in June 1994. If it finds satisfactory results, it could vote to recommend the FDA remove its conditional approval and grant full approval.
The drug, made by Bristol-Myers Squibb Co., is for treatment of HIV-infected adults who no longer respond to other therapies or cannot tolerate them.
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