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ICN's 8-MOP (METHOXSALEN) PHOTO-ACTIVATING AGENT APPROVED

Executive Summary

ICN's 8-MOP (METHOXSALEN) PHOTO-ACTIVATING AGENT APPROVED on March 23 for use with J&J's UVAR Photophoresis System in treating T-cell leukemia. ICN announced March 24 that FDA had approved a supplemental NDA for 8-MOP to treat cutaneous T-cell lymphoma in conjunction with J&J's extracorporeal photophoresis device -- a treatment where blood is removed from the patient, exposed to ultraviolet radiation, and returned to the patient. Marketed by J&J's Therakos subsidiary, UVAR received FDA approval nearly a year ago, on April 8, 1987, for use with methoxsalen to treat T-cell leukemia. Although the device has been available for nearly a year, and methoxsalen has been available even longer under the brandname Oxsoralen for use in PUVA (psoralen ultraviolet-A) therapy, the UVAR/8-MOP treatment has not been reimbursable pending FDA approval of the drug for the new use. Methoxsalen for the UVAR therapy will be marketed by the Elder unit of SPI Pharmaceuticals, ICN's drug subsidiary. Elder already markets Oxsoralen-Ultra, a 10 mg soft elastic gelatin capsule dosage from that has been available since January 1987 for use in PUVA treatments for psoriasis. The 8-MOP/UVAR treatment is indicated "for the palliative treatment of skin manifestation of cutaneous T-cell lymphoma in persons who have not been responsive to other forms of treatment, which include chemotherapy and radiation," according to the labeling. Cutaneous T-cell lymphoma, a form of leukemia, is a lymphocyte-mediated disorder similar to Hodgkin's disease that initially involves skin lesions, but can later progress to major organ and lymph node involvement, ICN noted. The treatment begins with the patient receiving 10 mg of methoxsalen. "Two hours later," ICN explained, "blood containing the drug is withdrawn from the patient and separated into erythrocyte- and leukocyte-enriched fractions." While the red blood cells are returned to the patient, "the leukocyte-enriched fraction (containing the target T-cells) is irradiated by ultraviolet A energy, before returning to the patient." A multicenter trial of UVAR/8-MOP conducted by Richard Edelson, MD, Yale University, which was reported in the Feb. 5, 1987 issue of the New England Journal of Medicine, served as the basis for the approval. The study showed that 27 of 37 patients with otherwise resistant cutaneous T-cell lymphoma responded to the UVAR/8-MOP therapy with "an average 64% decrease in cutaneous involvement," ICN noted.
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