The FDA's Antiviral Drugs Advisory Committee voted torecommend Syntex Corp.'s oral formulation of ganciclovir tomanage cytomegalovirus (CMV) retinitis in some late-stage AIDSpatients. Ganciclovir, a nucleoside analog marketed under the tradename Cytovene, is currently available only in an intravenous (IV)formulation that requires patients to sit still for up to two hours a daywhile the drug is administered through a surgically installed catheter.
Neither form of ganciclovir can cure CMV retinitis (inflammation ofthe retina), but the drugs do slow progression of the disease, whichafflicts more than 20 percent of all AIDS patients and can lead toprogressive loss of eyesight if untreated.
Although oral ganciclovir did not prove as effective as the IV formin slowing progression of CMV retinitis, FDA panel members agreedthat the benefits of oral administration outweighed the risks forcertain patients. Specifically, the panel recommended that the FDAapprove oral ganciclovir for treatment of immunocompromisedpatients whose retinitis has been stabilized by appropriate inductiontherapy and for whom the risk of a more rapid rate of diseaseprogression was balanced by the benefits of avoiding daily IVinfusions.
At least three AIDS activists groups spoke at the FDA meeting lastThursday, according to Syntex spokeswoman Linda Thomas.Spokespersons from the National Association of People with AIDS,the Treatment and Data Subcommittee of ACT-UP New York andthe San Francisco AIDS Foundation urged the panel to recommendapproval of oral ganciclovir based on its "quality of life advantage,"said Thomas.
The IV form of ganciclovir, launched in the U.S. in July 1989,generated sales of $85.5 million for Syntex in fiscal 1993 (ended inJuly). In the first half of fiscal 1994, sales were $44.1 million. LastMay, Roche Holdings Ltd., of Basel, Switzerland, made anacquisition offer for Syntex and the Palo Alto, Calif. company'sshareholders approved the merger on Oct. 28. Syntex will become aresearch-based affiliate of Roche Holdings.
If approved by the FDA, oral ganciclovir would be marketed andsold by Roche's U.S. subsidiary, Hoffman-La Roche Inc., based inNutley, N.J. _ Lisa Piercey
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