Leo Pharma's plaque psoriasis new drug Enstilar receives positive regulatory advice from EMA
March 25, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, LEO Pharma has received positive comments from the EMA academic review. Its plaque-type psoriasis drug Enstilar (calcium triol/betamethasone dipropionate) is expected to enter the European market at the end of the year for treatment of 18 years old. And above plaque psoriasis patients.
Enstilar (calcium triol/betamethasone dipropionate) is a daily-use, non-alcoholic foam formulation that can be used on most skin throughout the body for patient carrying and use.
The Enstilar listing application has now entered the European Union's decentralised procedure, based on a key Phase IIIa PSO-FAST clinical trial and a Phase II MUSE clinical safety trial. The PSO-FAST trial focused on the efficacy and safety of Enstilar for 4 weeks. The results showed that after 4 weeks of Enstilar treatment, more than half of the patients' lesions (IGA improvement score) could reach "disappear" or "substantial disappearance", and the PASI score decreased significantly by 75% compared with before treatment.
The first spray-type psoriasis drug - Enstilar
For the positive signal of the EMA release, Leo Pharmaceutical CEO Gitte Aabo commented: It is really exciting to get the academic approval. Yulio Pharmaceuticals is particularly profound in the case of millions of psoriasis patients in Europe.
It is reported that the academic review process is the last key step for the listing of new drugs in Europe. The academic review means that it is expected to obtain further authorization from 30 member states of the European Union. As early as October 2015, the FDA has officially approved Enstilar for the application of plaque psoriasis. According to the regulatory process, there are some speculations that Enstilar is expected to be approved by the EMA by the end of this year.
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