Phase III results show Enstilar (calcipotriol/betamethasone) reduces symptoms of itch in psoriasis-LEO Pharma

LEO Pharma has announced new data that shows aerosol foam Enstilar (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g), the Company's dual-action investigational aerosol foam for the treatment of psoriasis vulgaris, provided rapid itch relief and improvements in itch-related sleep loss for patients suffering from psoriasis. The data is from PSO-FAST, a Phase III clinical trial. Results found that 37% of patients using Enstilar had achieved improvements in itch after three days and 84% of patients using Enstilar achieved improvement in itch by week 4. Similarly, patients using Enstilar experienced improvements in itch-related sleep loss, with 36% improving after three days and 71% experiencing improvements by week 4.

Additional data from the PSO-FAST clinical trial showed that 81% of patients receiving Enstilar experienced clinically meaningful improvements in health-related quality of life (HRQoL). The new data was presented at the 23rd World Congress of Dermatology.

Comment: In December, LEO Pharma submitted a New Drug Application to the FDA for Enstilar and Marketing Authorization and applications were submitted to 30 Regulatory Agencies in Europe in March 2015.