Approved!

"The CHMP decided that Scenesse should be recommended for marketing authorisation under exceptional circumstances. This type of authorisation can be granted for medicines that offer new or improved treatment options for patients with no or only limited alternatives, in cases where the applicant is not able to provide comprehensive data. In the case of Scenesse, there is a lack of robust efficacy data due to the difficulties in conducting placebo-controlled trials in this indication. Patients recruited in these studies are not willing to expose themselves to sunlight for fear of developing painful symptoms; therefore, the beneficial effect of the medicine on phototoxicity is difficult to assess"