LEVERKUSEN, Germany I July 31, 2015 I Bayer HealthCare today announced that the U.S. Food and Drug Administration (FDA) has approved Finacea® (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. The approval is based on results from two pivotal clinical trials examining the efficacy and safety of Finacea® Foam compared to the foam vehicle (without the drug azelaic acid) in the topical treatment of papulopustular rosacea. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.
“With the FDA’s approval of Finacea Foam we can now offer patients suffering from rosacea in the US a new treatment option,” said Dr John O’Mullane, Head of Innovation, Research & Development at Bayer HealthCare’s Consumer Care division. “This demonstrates Bayer’s continued commitment to delivering innovation that meets the preferences and needs of patients with mild to moderate rosacea.”
In the two pivotal clinical trials, treatment with Finacea Foam resulted in a higher Investigator’s Global Assessment (IGA) success rate compared to vehicle control (32.1% vs. 23.4% in trial 1 and 43.4% vs. 32.5% in trial 2), as well as a greater reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period (-13.2 vs. -10.3 in trial 1 and -13.3 vs. -9.5 in trial 2). The most frequently observed adverse reactions in ? 0.5% of subjects treated with Finacea Foam included local application site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).
Finacea Foam will be available in the US by prescription only beginning in September 2015.
About the Clinical Trials
The efficacy and safety of Finacea Foam was evaluated in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials (Trials 1 and 2) in subjects with papulopustular rosacea, with a mean lesion count of 21.3 (range 12 to 50) inflammatory papules and pustules. A total of 1362 (active: 681; vehicle: 681) subjects aged 19 to 92 years (mean age = 50.6 years), 95.7% Caucasian, and 73.4% female participated in the trials. The severity of a subject’s rosacea was based on scoring from an IGA scale as well as a count of the inflammatory lesions.
In the clinical trials, subjects were randomized in a 1:1 ratio to receive either azelaic acid foam, 15% or its foam vehicle (without the drug azelaic acid) twice-daily for 12 weeks. Safety and tolerability were evaluated during the full 16-week study course, while the efficacy endpoints were assessed at the end of the 12-week treatment period. The efficacy endpoints were nominal change in inflammatory lesion count from baseline and success defined as a score of “clear” or “minimal” with at least 2-step reduction from baseline on a 5-point IGA.
About Rosacea
Rosacea is a chronic cutaneous disorder primarily affecting the convexities of the central face. There is no known cure. Rosacea is most frequently seen in adults between 30 and 50 years of age. Although the exact etiology of rosacea remains unknown, both genetic and environmental factors are thought to have an impact on the pathogenesis of this disease. To learn more about rosacea, please visit www.rosacea.org.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
SOURCE: Bayer HealthCare
Post Views: 27
LEVERKUSEN, Germany I July 31, 2015 I Bayer HealthCare today announced that the U.S. Food and Drug Administration (FDA) has approved Finacea® (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. The approval is based on results from two pivotal clinical trials examining the efficacy and safety of Finacea® Foam compared to the foam vehicle (without the drug azelaic acid) in the topical treatment of papulopustular rosacea. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.
“With the FDA’s approval of Finacea Foam we can now offer patients suffering from rosacea in the US a new treatment option,” said Dr John O’Mullane, Head of Innovation, Research & Development at Bayer HealthCare’s Consumer Care division. “This demonstrates Bayer’s continued commitment to delivering innovation that meets the preferences and needs of patients with mild to moderate rosacea.”
In the two pivotal clinical trials, treatment with Finacea Foam resulted in a higher Investigator’s Global Assessment (IGA) success rate compared to vehicle control (32.1% vs. 23.4% in trial 1 and 43.4% vs. 32.5% in trial 2), as well as a greater reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period (-13.2 vs. -10.3 in trial 1 and -13.3 vs. -9.5 in trial 2). The most frequently observed adverse reactions in ? 0.5% of subjects treated with Finacea Foam included local application site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).
Finacea Foam will be available in the US by prescription only beginning in September 2015.
About the Clinical Trials
The efficacy and safety of Finacea Foam was evaluated in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials (Trials 1 and 2) in subjects with papulopustular rosacea, with a mean lesion count of 21.3 (range 12 to 50) inflammatory papules and pustules. A total of 1362 (active: 681; vehicle: 681) subjects aged 19 to 92 years (mean age = 50.6 years), 95.7% Caucasian, and 73.4% female participated in the trials. The severity of a subject’s rosacea was based on scoring from an IGA scale as well as a count of the inflammatory lesions.
In the clinical trials, subjects were randomized in a 1:1 ratio to receive either azelaic acid foam, 15% or its foam vehicle (without the drug azelaic acid) twice-daily for 12 weeks. Safety and tolerability were evaluated during the full 16-week study course, while the efficacy endpoints were assessed at the end of the 12-week treatment period. The efficacy endpoints were nominal change in inflammatory lesion count from baseline and success defined as a score of “clear” or “minimal” with at least 2-step reduction from baseline on a 5-point IGA.
About Rosacea
Rosacea is a chronic cutaneous disorder primarily affecting the convexities of the central face. There is no known cure. Rosacea is most frequently seen in adults between 30 and 50 years of age. Although the exact etiology of rosacea remains unknown, both genetic and environmental factors are thought to have an impact on the pathogenesis of this disease. To learn more about rosacea, please visit www.rosacea.org.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
SOURCE: Bayer HealthCare
Post Views: 27
