LEO Pharma Announces New Drug Application Submission of the First Aerosol Foam for Plaque Psoriasis
PARSIPPANY, New Jersey, January 6, 2015 /PRNewswire/ --
LEO Pharma announces it has submitted a New Drug Application (NDA) for calcipotriene and betamethasone dipropionate aerosol foam, 0.005%/0.064%, to the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis.
(Logo: http://photos.prnewswire.com/prnh/20130221/595427 )
The first aerosol foam formulation of the fixed combination calcipotriene/betamethasone dipropionate has been developed with the aim of improving treatment for patients with plaque psoriasis - the most common clinical form of psoriasis.
The regulatory submission in the US is based on studies of patients with plaque psoriasis. These include the Phase 3a PSO-FAST study which evaluated efficacy and safety at four weeks[1] and the Phase 2 MUSE safety study.[2]
Barbara J. Osborne, President and CEO, commented:
"Psoriasis is a chronic, debilitating disease. Patients with inadequately managed plaque psoriasis can experience substantial burden of illness, with similar reductions in quality of life to those experienced by patients with diabetes or cancer.[3]
With the regulatory submission announced today, we are taking a step further towards providing additional topical treatment options for people living with psoriasis."
Regulatory filings in Europe and other countries are planned during the course of 2015 and 2016.
With this latest submission, LEO Pharma demonstrates a strong commitment to dermatology.
NOTES TO EDITORS
About Psoriasis
Psoriasis is a chronic, inflammatory disease, which is frequently accompanied by multiple physical and/or psychological comorbidities, such as metabolic syndrome and psoriatic arthritis.[3]
Plaque psoriasis is estimated to affect about 2-4% of the population in the US.[3] 80% of patients are affected by plaque psoriasis - the most common clinical form of psoriasis.[3]
Topical treatments are first-line therapies for the majority of patients since approximately 80% of the patients have mild or moderate plaque psoriasis.[3]
About LEO Pharma
Founded in 1908, LEO Pharma is an independent, research-based pharmaceutical company. LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally. The company has its own sales forces in 61 countries and employs around 4,800 people worldwide. LEO Pharma is headquartered in Denmark and is wholly owned by the LEO Foundation.
For more information visit http://www.leo-pharma.us
References
1. LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris. 2013. ClinicalTrials.gov Identifier: NCT01866163.
2. Taraska V, et al. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Presented at the Skin Disease Education Foundation's 15th Annual Las Vegas Dermatology Seminar & the 11th Annual SDEF Psoriasis Forum, October 30-November 1, 2014. Abstract #13
3. Parisi R, et al. Global Epidemiology of Psoriasis: A Systematic Review of Incidence and Prevalence. The Society for Investigative Dermatology. J Invest Dermatol 2013;133(2):377-85
Global Media Contact
Polly Lutter
Senior Global Communications Manager
LEO Pharma A/S, Denmark
polly.lutter@leo-pharma.com
Tel: +45-41-37-12-27
Help employers find you! Check out all the jobs and post your resume. Amanda Agostino Client Executive, Burson-Marsteller amanda.agostino@bm.com Tel: +1-(212)-614-4129
LEO Pharma announces it has submitted a New Drug Application (NDA) for calcipotriene and betamethasone dipropionate aerosol foam, 0.005%/0.064%, to the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis.
(Logo: http://photos.prnewswire.com/prnh/20130221/595427 )
The first aerosol foam formulation of the fixed combination calcipotriene/betamethasone dipropionate has been developed with the aim of improving treatment for patients with plaque psoriasis - the most common clinical form of psoriasis.
The regulatory submission in the US is based on studies of patients with plaque psoriasis. These include the Phase 3a PSO-FAST study which evaluated efficacy and safety at four weeks[1] and the Phase 2 MUSE safety study.[2]
Barbara J. Osborne, President and CEO, commented:
"Psoriasis is a chronic, debilitating disease. Patients with inadequately managed plaque psoriasis can experience substantial burden of illness, with similar reductions in quality of life to those experienced by patients with diabetes or cancer.[3]
With the regulatory submission announced today, we are taking a step further towards providing additional topical treatment options for people living with psoriasis."
Regulatory filings in Europe and other countries are planned during the course of 2015 and 2016.
With this latest submission, LEO Pharma demonstrates a strong commitment to dermatology.
NOTES TO EDITORS
About Psoriasis
Psoriasis is a chronic, inflammatory disease, which is frequently accompanied by multiple physical and/or psychological comorbidities, such as metabolic syndrome and psoriatic arthritis.[3]
Plaque psoriasis is estimated to affect about 2-4% of the population in the US.[3] 80% of patients are affected by plaque psoriasis - the most common clinical form of psoriasis.[3]
Topical treatments are first-line therapies for the majority of patients since approximately 80% of the patients have mild or moderate plaque psoriasis.[3]
About LEO Pharma
Founded in 1908, LEO Pharma is an independent, research-based pharmaceutical company. LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally. The company has its own sales forces in 61 countries and employs around 4,800 people worldwide. LEO Pharma is headquartered in Denmark and is wholly owned by the LEO Foundation.
For more information visit http://www.leo-pharma.us
References
1. LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris. 2013. ClinicalTrials.gov Identifier: NCT01866163.
2. Taraska V, et al. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Presented at the Skin Disease Education Foundation's 15th Annual Las Vegas Dermatology Seminar & the 11th Annual SDEF Psoriasis Forum, October 30-November 1, 2014. Abstract #13
3. Parisi R, et al. Global Epidemiology of Psoriasis: A Systematic Review of Incidence and Prevalence. The Society for Investigative Dermatology. J Invest Dermatol 2013;133(2):377-85
Global Media Contact
Polly Lutter
Senior Global Communications Manager
LEO Pharma A/S, Denmark
polly.lutter@leo-pharma.com
Tel: +45-41-37-12-27
Help employers find you! Check out all the jobs and post your resume. Amanda Agostino Client Executive, Burson-Marsteller amanda.agostino@bm.com Tel: +1-(212)-614-4129