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| |  FDA Approves Panretin Gel For AIDS-Related Kaposi's Sarcoma SAN DIEGO, CA -- Feb. 3, 1999 -- The United States Food and Drug Administration has approved Ligand Pharmaceuticals Inc.’s Panretin(R) gel (alitretinoin) 0.1% for the topical treatment of cutaneous lesions of patients with AIDS-related Kaposi's sarcoma (KS). "Panretin gel is the first patient-applied treatment for AIDS-related KS and represents a significant new option to the traditional management of this disease," said Steven Miles, M.D., associate professor of medicine, UCLA C.A.R.E. Center, and a leading clinical investigator in the Panretin gel trials. “Panretin gel offers patients a self-administered, non-invasive alternative to currently available therapies." Patients may apply Panretin gel to their KS skin lesions in the privacy of their homes twice a day or as instructed by their physicians. This application regimen is expected to save patients significant time and money compared to other therapies, which require periodic visits to the doctor's office, clinic or hospital and the administration of the treatment by a doctor or nurse (collectively called collateral costs). FDA clearance followed a review by its oncologic drugs advisory committee on Nov. 16, 1998, at which the committee recommended Panretin gel approval in a series of eight to one votes. In making that recommendation, the committee reviewed data from two Phase III clinical trials: one conducted internationally at 22 sites in Europe, Australia and the U.S., and one conducted at 35 sites in North America. These two trials plus earlier human studies included 385 patients. Final results of the North American trial, which were released in December 1997, demonstrated that 35 percent of patients treated with Panretin gel experienced complete or partial response compared to 16 percent of patients applying vehicle gel. Both Phase III trials were designed to evaluate safety and efficacy of Panretin gel in patients with cutaneous AIDS-related KS. Protocols for the trials called for patients to be treated with either Panretin gel or vehicle gel, applied two to four times daily to KS skin lesions for at least 12 weeks. Patients were assessed at two, four, eight and 12 weeks. Responses were defined using AIDS Clinical Trials Group (ACTG) criteria as applied to topical therapy of designated KS index lesions. After 12 weeks, qualifying patients could continue treatment with open-label Panretin gel. In clinical trials to date, Panretin gel was generally well tolerated. Side effects were primarily mild to moderate and included in most patients erythema (redness) or skin irritation occurring nearly exclusively at the application site. Skin toxicity, including more intense erythema, edema (swelling) and vesiculation (blistering), caused only seven percent of the patients to withdraw from the studies. In both studies, responses occurred in patients with a wide range of baseline CD4+ lymphocyte counts, including patients with CD4+ lymphocyte counts less than 50 cells/mm3. Nearly all patients received concomitant combination antiretroviral therapy. KS is the most frequent malignancy seen in AIDS patients and is often characterised by multi-focal, widespread lesions at the onset of illness and may involve the skin, oral mucosa, lymph nodes and visceral organs, such as the lung and gastrointestinal tract. The company estimates that between 30,000 and 50,000 patients in the U.S. and Western Europe, where Ligand intends to be the primary marketer for Panretin gel, are affected by the disease. Related Links: Panretin, Ligand Pharmaceuticals Inc.
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