Amryt Pharma announces positive results from pivotal phase 3 “EASE” trial
Latest press release about EASE trial, November 2020:
Amryt is one step closer to an application of market authorization of FILSUVEZ®. They finished a detailed data analysis and released the results. They show that RDEB patients benefit most from the treatment with FILSUVEZ®. It showed an acceptable safety profile and hence Amryt prepares the submission to authorities in the US and EU.
Find the statement here.
Recently Amryt Pharma reported about the positive results of the phase III EASE study, testing a topical therapeutic gel with the brand name FILSUVEZ®. Currently, there are good signs that this gel will be the first approved treatment for dystrophic and junctional EB worldwide.
The "EASE" study was a 3-month randomised, double-blind, placebo-controlled international phase 3 trial. It involved 223 patients with junctional and dystrophic EB from 28 different countries. The primary endpoint of the study was to compare the efficacy of FILSUVEZ® versus the control gel, according to the proportion of patients with complete wound closure within 45 days of treatment.
We have asked Dr. Sophie Kitzmüller, who coordinated the study at EB Study Centre of the EB House Austria, to provide an initial assessment of the preliminary results:
‘The fact that this gel is likely to be the first approved symptomatic therapy for EB is great news for the EB community. The statistical analysis published so far states a difference in the response rate between the active substance and the placebo. We are keen on detailed data being published and trust that they show that the treatment is effective and safe. Then it can become a valuable addition to the EB patient’s care routine. Amryt sincerely thanks all the study participants in their press release. Patient participation is of utmost importance for the development of new therapeutic options. The next steps are now a more detailed analysis of the data and then a submission to the regulatory authorities (FDA and EMA) for approval. However, there are still many months or even years between the submission and the actual availability of the product. The authorities will carefully review all submitted data (especially safety and adverse reaction data), . Therefore, we hopethat the ointment will be available in 1-2 years.‘
Acess the full Amryt Pharma press release by clicking here.