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news.Canadian biotech QLT Inc. said that the FDA has accepted for filing and review a label change for its acne drug Aczone to request the removal of the glucose-6-phosphate dehydrogenase (G6PD) screening and blood monitoring requirements.
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A decision by the FDA on the label revision is expected by the end of March 2008. “We are pleased to report the FDA acceptance of this filing as it represents another step toward achieving an important milestone for the company. Aczone has the potential to be a key contributor to our growth if this label revision is ultimately approved by the FDA,” said Bob Butchofsky, president and CEO of QLT.
The sNDA submitted at the end of May 2007 is primarily based on the phase IV clinical trial completed in 56 safety-evaluable G6PD-deficient patients. This study demonstrated no clinical evidence of hemolytic anemia in this patient population.
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 analyzed by third party clinical experts in dermatology and hematology who concluded that no clinically meaningful changes in safety-related parameters were observed in the trial.