3M has received an “approvable” letter from the U.S. Food and Drug Administration (FDA) in response to its supplemental new drug application on Aldara (imiquimod) Cream, 5% for the treatment of superficial basal cell carcinoma (sBCC), a common form of non-melanoma skin cancer.
The FDA noted no major deficiencies in the application and requested 3M provide additional safety data as a condition of approval. 3M plans to submit such additional data from completed clinical studies shortly. Given that FDA review of the additional data will take up to six months, 3M now expects potential approval in the second half of 2004.
Last month, the FDA approved Aldara cream as a treatment option for certain patients with actinic keratosis (AK), a pre-cancerous skin disease caused by cumulative sun exposure. The response from dermatologists since 3M launched Aldara cream as an AK treatment option has been favorable.
Aldara cream is the first and only patient-applied immune response modifier and is available by prescription only. Full prescribing information is available at www.3M.com/Aldara.