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