LEO Pharma announced it has submitted a New Drug Application to the US Food and Drug Administration (FDA) for calcipotriene/betamethasone dipropionate aerosol foam 0,005%/0,064% for the treatment of psoriasis vulgaris.
The novel aerosol foam formulation of the fixed combination calcipotriene/betamethasone dipropionate has been developed with the aim of improving treatment for patients with psoriasis vulgaris[1,2] – the most common clinical form of psoriasis.
The regulatory submission in the US is based on studies of patients with psoriasis vulgaris. These include the Phase 3a PSO-FAST study which evaluated efficacy, safety, itch relief and itch-related sleep loss across a four week period, and the Phase 2 MUSE safety study.
Kim Kjøller, Senior Vice President, Global Development, commented:
“Psoriasis is a chronic, debilitating disease. Patients with inadequately managed psoriasis can experience substantial burden of illness, with similar reductions in quality of life to those experienced by patients with diabetes or cancer.
With the regulatory submission announced today, we are taking a step further in our mission towards reducing this burden by making calcipotriene/betamethasone dipropionate aerosol foam available 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 reinforces a strong commitment to dermatology.
Psoriasis is a chronic, inflammatory disease, which is frequently accompanied by multiple physical and/or psychological comorbidities, such as metabolic syndrome and psoriatic arthritis.
Psoriasis is estimated to affect about 2-4% of the population in western countries. 80% of patients are affected by psoriasis vulgaris – the most common clinical form of psoriasis.
Topical treatments are first-line therapies for the majority of patients since approximately 80% of the patients have mild or moderate psoriasis.
1 Hollesen Basse L, et al. Enhanced in vitro skin penetration and antipsoriatic effect of fixed combination calcipotriol plus betamethasone dipropionate in an innovative foam vehicle. Journal of Investigative Dermatology 2014; 134(S30): abstract 192
2 Queille-Roussel C, et al. Antipsoriatic effect of a novel aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis, using a modified psoriasis plaque test. Presented at the Fall Clinical Dermatology Conference, Encore, Las Vegas, October 16-19, 2014
3 Reich K, et al. Efficacy of a fixed combination of with calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicentre, randomized, controlled, prospective study. Journal of European Academy of Dermatology Venereology 2014: October (epub ahead of print) DOI: 10.1111/jdv.12774
4 LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris. 2013. ClinicalTrials.gov Identifier: NCT01866163.
5 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
6 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