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ROCHE's TEGISON APPROVAL AS SECOND LINE THERAPY FOR SEVERE PSORIASIS RECOMMENDED BY FDA CMTE,; LABEL SHOULD CARRY STRONG TERATOGENIC WARNING

Executive Summary

Roche's second generation retinoid Tegison (etretinate) should be approved as second line therapy in the treatment of severe recalcitrant psoriasis, particularly the erythrodermic or pustular types, FDA's Dermatologic Drugs Advisory Cmte. recommended at its June 24 meeting. Roche's Tegison NDA is based on 20 clinical trials conducted in the U.S. involving a total of 495 etretinate treated patients. The pivotol clinical presented to the cmte. was a five-center trial comparing 57 etretinate patients with 61 placebo patients after eight weeks of treatment. The firm stated that global evaluation of improvement, ranging from definitely worse to totally clear, showed that 94.7% etretinate treated patients improved to 23.5% for placebo., Of the active treated patients, 78.9% showed at least marked improvement compared to 6.6% for placebo. In recommending approval, the cmte. agreed that the product's efficacy outweighed concern about the drug's adverse effects, including teratogenicity. Explaining why he recommended approval, cmte. member John Kenney, MD, Howard University, noted the cmte. concerns about teratogenicity and commented: "If I were faced with a patient with psoriasis like we've seen here today and the question is whether they might have children way down the line somewhere. . .it would not concern me. . . as much as giving that patient a great deal of relief from their situation." Roche proposed that contraception be indicated for women of childbearing age for one month prior to, and one year subsequent to, etretinate treatment. However, because the drug is stored in fat cells and has a half life of 120 days, several cmte. members suggested that women should remain on contraceptives for up to three years after treatment. The firm told the cmte. that it would initiate an educational program for etretinate very similar to the program it developed for Accutane. Roche said it would prepare a patient package insert to be available in sets of four inside each package of 100 tablets for pharmacist dispensing. Roche also said it will make available a "product monograph" summarizing all the formal statistical data submitted in the NDA. Roche noted that etretinate may also cause an altering of lipid levels, including increased cholesterol, increased triglycerides, and lowered HDL levels; ophthalmological problems, including the feeling of dry eyes, loss of eyebrow hair and eyelashes; and bone changes. A company consultant told the cmte. that use of etretinate by patients without severe psoriasis would not be a problem because "unless a patient has a fairly substantial case of this disease the. . .cutaneous side effects will be worse than a minor form of psoriasis." He also told the cmte. that side effects "virtually disappear" once you "stop the drug or lower the dose." One of the issues the cmte. was concerned about was the possibility that many patients would receive continuous dosing. A Roche representative noted that the firm's proposal is to label etretinate for use as intermittent therapy. Commenting on the dosage regimen, cmte. member James Rasmussen, MD, University of Michigan Medical School, said that because of the frequence of psorisis recurrence after therapy, "I have a feeling that the drug would not be used as intermittently as it had been used in protocols. My experience with methotrexate is not many patients are able to completely discontinue the drug." With continuous dosing, Rasmussen continued, "I'm not as concerned about the hepatoxic or the ophthalmological or the orthopedic problems as I am about the reproductive problems. . . I'm really concerned that this drug is going to get out and we're going to be faced with a generation of young women who are to be faced with the choice of not treating the disease or not having children."

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