Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
The Associated Press - 5 Sep 95
Hoffmann-La Roche, of Nutley, N.J., is asking for FDA approval of saquinavir, a compound that attacks the reproduction cycle of the AIDS virus in a way different from that of drugs now in use.
Saquinavir acts on HIV, the virus that causes AIDS, by blocking an enzyme called proteinase, which has a key role in the final phases of the replication cycle of HIV. Four HIV drugs currently marketed work by blocking reverse transcriptase, a protein active earlier in the replication cycle.
Saquinavir has been tested extensively in Europe, and researchers report that it is effective for a time against HIV. The drug was shown in clinical trials to reduce the amount of virus in patients' blood and to increase the number of CD4 cells, the immune cells that are the principal targets of HIV. However, the studies show that HIV eventually develops resistance to the drug, a problem that is seen in all of the other AIDS drugs.
Some studies have shown that saquinavir was particularly effective when used in combination with other anti-HIV drugs. Hoffmann-La Roche officials claim that saquinavir has fewer toxic side effects than the other antiviral drugs now in use.
Arthur Whitmore, a spokesman for the FDA, said the AIDS community is anxious to have saquinavir available and the agency is poised to take quick action.
"We're prepared to move within four to six months," Whitmore said.
If approved, saquinavir will be marketed by Hoffmann-La Roche under the brand name Invirase.
Copyright 1995/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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