QLT Inc. announced that QLT USA, Inc. has submitted a labelling supplement (sNDA) for Aczone to the US 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 haemolytic anaemia in this patient population. A decision by the FDA on the label revision is expected to take approximately 10 months.
"This filing represents a significant milestone in our Aczone programme and in our efforts to bring the first new compound in a decade for the treatment of acne to patients in the US," said Bob Butchofsky, president and chief executive officer of QLT. "If the FDA approves the label revision we believe Aczone could be a key contributor to our growth strategy with a potential launch of Aczone in 2008."
The phase IV clinical trial of Aczone was performed to meet a post-approval commitment requested by the FDA. The purpose of this study was to gather more information about the safety of Aczone, a prescription topical medicine, in treating patients with acne who have G6PD deficiency. During a six-month period, patients were treated with both Aczone and the Aczone-vehicle (control group) in a cross-over design. Data was analysed by third party clinical experts in dermatology and haematology who concluded that no clinically meaningful changes in safety-related parameters were observed in the trial.
QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development and commercialisation of innovative therapies. Our research and development efforts are focused on pharmaceutical products in the fields of ophthalmology and dermatology. In addition, we utilize two unique technology platforms, photodynamic therapy and Atrigel, to create products such as Visudyne and Eligard.