LEO Pharma receives EU scientific approval of Enstilar® for the treatment of psoriasis

LEO Pharma announced that it received scientific approval of Enstilar^® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0.5mg/g)  for the treatment of psoriasis vulgaris in patients 18 years of age or older. Enstilar^® is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.¹

“The scientific approval of Enstilar^® is exciting news, not only for LEO Pharma but also for the millions of Europeans living with psoriasis,” said Gitte Aabo, President and CEO of LEO Pharma.  “Enstilar^® is a first-of-its-kind topical spray foam and we believe it will help people living with psoriasis by providing a new type of treatment option that they are looking for.”

Enstilar^® was developed to treat patients with psoriasis vulgaris2,3 – the most common clinical form of psoriasis.⁴ In Europe, nearly four million people are living with psoriasis.⁵

The application in the EU decentralised procedure for Enstilar® was based on the pivotal Phase 3a PSO-FAST study which evaluated the efficacy and safety profile across a four week period,⁵ and the Phase 2 MUSE safety profile study.⁶  In the PSO-FAST clinical trial, over half of patients treated with Enstilar^® were “Clear” or “Almost Clear” by Week 4 as measured by the Investigator Global Assessment (IGA) improvement score.¹ Additionally, more than half of patients treated with Enstilar^® achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.⁷

The scientific approval means that LEO Pharma has received a positive outcome of the decentralised procedure.  Receiving this positive outcome is the final step before national marketing authorisations can be granted by the 30 EU countries, which are part of the procedure.  The national approvals of Enstilar^® are expected later this year.  In October 2015, Enstilar® was approved for use by the US Food and Drug Administration (FDA).

References

1. Enstilar® SmPC; 2016
2. 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
3. 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, 16–19 October 2014
4. 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. J Eur Acad Dermatol Venereol 2014. DOI: 10.1111/jdv.12774.
5. EFPIA Who does psoriasis affect? Available at www.efpia.eu/diseases/134/59/Psoriasis.  Last accessed on 9 February 2016.
6. LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris. 2013. ClinicalTrials.gov Identifier:NCT01866163.
   7.    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.