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FDA approval granted for immune response modifier for precancerous skin lesions.
2004 MAR 31 - (NewsRx.com & NewsRx.net) -- According to the American Academy of Dermatology, actinic keratosis (AK) affects as many as 10 million Americans each year.
Caused by chronic sun exposure, actinic keratoses are precancerous skin lesions, many of which can occur on the face and scalp.
3M announced that the U.S. Food and Drug Administration (FDA) 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 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, a common form of nonmelanoma skin cancer.
Clinical trials demonstrated that most patients treated with Aldara cream achieved clearance of 75% 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.
The FDA's approval of Aldara cream for AK is based on positive results from two double-blind, randomized, 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 ...
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...The on-label dosing of ALDARA Cream in the treatment of AK is twice weekly for 16 weeks...e.g., 5 cm x 5 cm). ALDARA cream should be applied to the entire...have not been established for ALDARA Cream in the treatment of actinic...
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