3M Pharmaceuticals Obtains FDA Approval for First Immune Response Modifier to Treat Actinic Keratosis.Business Editors/Health/Medical Writers ST. PAUL, Minn.--(BUSINESS WIRE)--March 3, 2004 Patient-applied Aldara Cream clears precancerous skin lesions According to the American Academy of Dermatology The American Academy of Dermatology (AAD) is the largest organization of dermatologists in the world. The Academy grants Fellowships and Associate Memberships, as well as Fellowships for Nonresidents (of the United States of America or Canada). , actinic keratosis (AK) affects as many as 10 million Americans each year. Caused by chronic sun exposure, actinic actinic /ac·tin·ic/ (ak-tin´ik) producing chemical action; said of rays of light beyond the violet end of the spectrum. ac·tin·ic adj. keratoses are precancerous skin lesions, many of which can occur on the face and scalp. 3M announced today the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted marketing approval for Aldara (imiquimod) cream, 5%, a topical prescription treatment for clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent im·mu·no·com·pe·tent adj. Having the normal bodily capacity to develop an immune response following exposure to an antigen. im adults. Aldara cream is the first immune response modifier (IRM) approved for AK. "Aldara's approval for actinic keratosis represents an important addition to current treatment approaches," stated Barry Labinger, division vice president, 3M Pharmaceuticals Division. Labinger also confirmed that the FDA currently is reviewing the sNDA (supplemental new drug application) for Aldara cream in the treatment of superficial basal cell carcinoma basal cell carcinoma n. A slow-growing, locally invasive, but rarely metastasizing neoplasm of the skin derived from basal cells of the epidermis or hair follicles. Also called basal cell epithelioma. , a common form of nonmelanoma skin cancer nonmelanoma skin cancer 1 Basal cell carcinoma, see there 2 Squamous cell cancer, see there 3. Skin adnexal carcinoma 4. Cutaneous lymphoma . Clinical trials demonstrated that most patients treated with Aldara cream achieved clearance of 75 percent or more of their AK lesions, and nearly half experienced complete clearance. The FDA's approval for AK reinforces 3M's confidence in the potential of the company's IRM compounds, according to Labinger. "We look forward to expanding the IRM portfolio to treat a variety of diseases," he said. Clinical Studies The FDA's approval of Aldara cream for AK is based on positive results from two double-blind, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , placebo-controlled clinical trials involving 436 patients with multiple AK lesions. Patients were treated with Aldara cream or placebo twice a week for 16 weeks. Nearly half of the patients treated with Aldara cream achieved complete clearance of all lesions compared to only 3 percent in the placebo group. A majority of patients experienced lesion clearance of 75 percent or more. The clinical studies also revealed another important feature of Aldara cream. Among patients treated with Aldara cream, a number of previously undetectable lesions appeared and cleared during treatment. "Recent studies suggest that chronic sun exposure may cause immunosuppression immunosuppression Suppression of immunity with drugs, usually to prevent rejection of an organ transplant. Its aim is to allow the recipient to accept the organ permanently with no unpleasant side effects. in the skin," stated lead investigator Mark G. Lebwohl, M.D., FACP FACP Fellow of the American College of Physicians. FACP abbr. 1. Fellow of the American College of Physicians 2. Fellow of the American College of Prosthodontists , professor and chairman, Department of Dermatology, Mount Sinai Medical Center, New York, N.Y. "Aldara, an immune response modifier, is an exciting treatment advance for patients with AK." The most frequently reported adverse reactions were local skin reactions, including erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. , flaking/scaling/dryness, scabbing/crusting, edema, erosion/ulceration, weeping/exudates, and itching/ burning at the application site. Only 2 percent of patients reported pain at the lesion site. While 16 percent of patients had a rest period during treatment, only 2 percent discontinued treatment due to local skin or application-site reactions. About Actinic Keratosis Actinic keratosis appears as rough, red, scaly patches, or crusts on the skin. AK lesions usually measure less than one quarter inch in diameter and more than 80 percent of lesions occur on the upper limbs, head and neck. Individuals with fair skin, light hair and light-colored eyes are at greatest risk for AK. Because AK is caused by cumulative sun exposure, it can take years to develop. The condition usually appears first in older people, although cases have been reported in people in their 40s. Common AK treatments include cryotherapy Cryotherapy Definition Cryotherapy is a technique that uses an extremely cold liquid or instrument to freeze and destroy abnormal skin cells that require removal. (freezing), excisional surgery, electrodesiccation (burning) and curettage curettage /cu·ret·tage/ (ku?re-tahzh´) [Fr.] the cleansing of a diseased surface, as with a curet. medical curettage , lasers, topical chemotherapy and photodynamic therapy. For more information about Aldara cream, AK or for full prescribing information, call 1-877-4-AK-NEWS, or visit www.aldara.com. About 3M Pharmaceuticals 3M Pharmaceuticals, a division of 3M Health Care, develops, manufactures and sells branded prescription drug products related to dermatology, women's health, sexual health, cardiology and respiratory medicine. Additional information is available at www.3M.com/pharma. 3M Health Care, the largest of 3M's seven business segments, is dedicated to improving the practice, delivery and outcome of care in medical, dental, pharmaceutical, health information systems and personal care markets. Aldara is a trademark of 3M. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion