By: Q L T  09-12-2011

Aczone™ has been approved for the topical treatment of acne vulgaris. Aczone is an aqueous topical gel containing 5% dapsone, an anti-inflammatory and anti-microbial drug. Aczone was developed by QLT's wholly owned subsidiary, QLT USA, Inc., and was approved in the United States in 2005 and in Canada in 2006. Due to a label restriction that would likely impact its use in the marketplace Aczone has not yet been commercially marketed.  Aczone currently has a label restriction that requires patients to be screened to detect if they are predisposed to a type of anemia (hemolytic anemia) due to a deficiency in a specific enzyme, Glucose 6-phosphate dehydrogenase (G6PD). Patients who have this enzyme deficiency will need to be monitored by their physicians through regular blood counts when Aczone is prescribed.In May 2007 QLT submitted a labeling supplement (sNDA) for Aczone to the U.S. Food and Drug Administration (FDA) to request the removal of the glucose-6-phosphate dehydrogenase (G6PD) screening and blood monitoring requirements from its current label. The sNDA is primarily based on the Phase IV clinical trial completed in 56 safety-evaluable G6PD-deficient patients (see related press-release issued November 7, 2006). This study demonstrated no clinical evidence of hemolytic anemia in this patient population. A decision by the FDA on the label revision is expected to take approximately 10 months.

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