The supplemental new drug application (sNDA) submitted at the end of May 2007 was primarily based on the Phase IV clinical trial completed in 56 safety-evaluable glucose-6-phosphate dehydrogenase (G6PD) deficient patients. This study demonstrated no clinical evidence of hemolytic anemia in this patient population.
Aczone is said to be the only acne treatment to harness the potential of dapsone in a topical formulation to provide patients with a convenient and effective therapy. QLT USA owns worldwide marketing rights to Aczone.
Bob Butchofsky, president and CEO of QLT, said: “We are extremely pleased to report the FDA decision to change the Aczone label as it validates QLT’s clinical, regulatory and commercialization strategy for this product. Management believed in the product and took the necessary steps to address the FDA’s needs, ultimately dramatically enhancing the value of Aczone.”