ACZONE GEL IS APPROVED FOR THE TREATMENT OF ACNE BY THE

QLT has announced that it has received final approval from the FDA to market Aczone (dapsone) Gel, 5 percent for the topical treatment of acne vulgaris.

Patients will need to be screened to detect if they are predisposed to one type of anemia (hemolytic anemia) because of a specific enzyme deficiency, G6PD (Glucose 6-phosphate dehydrogenase) deficiency. Patients who have this enzyme deficiency will need to be monitored with regular blood counts.

In the Aczone clinical trial program, 1.4 percent of about 3,500 patients had this disorder which is consistent with the incidence in the general North American population. Certain populations, mainly males of African-American descent, have a higher reported incidence of approximately 10-14 percent. QLT will undertake a postapproval Phase IV study in 50 acne patients who have G6PD deficiency and follow them for six months, after which QLT expects to submit an application to the FDA to re-evaluate the Aczone label.