Chiron Corp. came one step closer to final FDA approval of itsdrug for treating multiple sclerosis last week. On Thursday theagency informed Chiron (NASDAQ:CHIR) that it will approveBetaseron (a recombinant form of beta-interferon) once the company supplies FDA with certain"information." That information, explained Larry Kurtz, Chiron'svice president of corporate communications, is "what youwould expect at the final stages of review with FDA. Labeling isthe most obvious. "FDA's requests are "straightforward," Kurtzsaid."There weren't any surprises." In fact, Kurtz added, Chiron ofEmeryville, Calif., has already supplied some of thatinformation to the agency. Betaseron is the first biologic toreceive an "approvable letter," something that the FDA hadreserved heretofore for medical devices, Kurtz told BioWorld.The action is part of the agency's revised modus operandi, inwhich approvable letters will become "standard.Under the new regulations (which are aimed at speeding updrug approvals), FDA is required to be very clear," said Kurtz,notifying a company by letter within 12 months of its productlicense application (PLA) whether the biological product isapprovable or not. For Betaseron, "it appears that FDA isapplying these standards already," Kurtz added. Chiron and itsmarketing partner, Berlex Laboratories (the U.S. subsidiary ofSchering AG),filed the product licensing application (PLA) forBetaseron in June 1992.
An FDA advisory committee in March voted 7-2 to recommendapproval of Betaseron for treating relapsing-remitting multiplesclerosis. Once the FDA approval is final, it will still take "atleast six weeks and probably longer" before Chiron can ship thedrug to Berlex for marketing, said Kurtz. The lag will come inthe time it takes Chiron, the manufacturer, to come up with thefinal versions of the labeling, the package inserts and otheraspects of packaging. The company has already beenaccumulating inventories of the drug per se, Kurtz toldBioWorld.
Chiron's stock closed at $59.13 a share on Tuesday, off 38 cents.
-- Jennifer Van Brunt Senior Editor
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