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THERAKOS/ICN’s UVAR/OXSORALEN TRIAL IS "UP AND RUNNING"

Executive Summary

THERAKOS/ICN's UVAR/OXSORALEN TRIAL IS "UP AND RUNNING" for the combination therapy for severe scleroderma, FDA Commissioner Kessler announced at a March 16 budget hearing before the House Appropriations/Agriculture Subcommittee. "What we have done," Kessler said, is "to sit down and work with the sponsor, to work with the scientists...in making sure that the study is adequately designed." He said the new protocol "will answer the questions that we think need to be answered," adding that "we're on our way to getting the data, once and for all, on that product." Kessler was before the subcommittee to give testimony on user fee legislation (see preceding T&G). The protocol for the use of Therakos' UVAR photopheresis device with ICN Pharmaceutical's drug Oxsoralen (methoxsalen) was agreed to by Therakos after meetings with the agency. Guidelines for clinical testing of scleroderma treatments were discussed by the agency's Arthritis Drugs Advisory Committee Sept. 23 ("The Pink Sheet" Sept. 28, 1992, T&G-12). Therakos said March 19 that patient enrollment has begun at the 14 centers in the U.S. that will participate in the trial. The double-blind, placebo-controlled protocol calls for the enrollment of approximately 80 patients, the company said. The data should be collected and evaluated by late 1994. ICN and Therakos had withdrawn their NDA after arguing that previously submitted data would not receive a fair appraisal by FDA reviewers ("The Pink Sheet" Jan. 27, 1992, p. 3). Asked by Rep. DeLauro (D-Conn.) about the delay in approving the combination therapy, Kessler replied: "The unfortunate part about the photopheresis issue involving scleroderma is that the [earlier] studies...did not show in any convincing way that the therapy worked." The subcommittee's questions about the photopheresis treatment are not the first example of congressional interest in the drug- device combination. In March 1992, Rep. Dingell (D-Mich.) wrote Kessler a letter urging FDA to expedite studies of the product ("The Pink Sheet" April 20, 1992, T&G-9). This followed a congressional hearing at which Dingell concluded that miscommunication between the sponsors and FDA was responsible for delays in the development of a protocol for the photopheresis treatment ("The Pink Sheet" Feb. 10, 1992, p. 6). Kessler acknowledged that people with scleroderma, which can be life-threatening, generally cannot get insurance coverage for unapproved treatment regimens like photopheresis. The solution, he said, is coverage by health insurers of experimental products for serious illnesses when no alternative therapies are approved. The issue now for scleroderma patients "is what do we do in the interim; what do you do while you're waiting for the data, especially when people don't have time to wait?" he said. "There's no reason why, at least from our standpoint, insurance companies should not cover" experimental therapies "if patients have no other alternative," the commissioner asserted.
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