EMA recommends adding efficacy data to Apealea label

Oasmia Pharmaceutical announced that the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a type II variation application to add efficacy data to the Apealea (paclitaxel water-soluble formulation) product information. The marketing authorisation approval for Apealea in the EEA was based on the phase III pivotal study OAS?07OVA. The study was conducted on 789 randomized patients with relapse of ovarian cancer disease that were treated with paclitaxel in combination with carboplatin.

The results of the subpopulation analysis of the patients corresponding to the approved indication, i.e patients experiencing their first relapse, were based on 301 patients (Apealea arm) and 298 patients (Comparator arm). The positive opinion of the application allows the product information to present all available efficacy data for Apealea for the approved indication in addition to the data describing the entire population. This change may be implemented after completion of the review process of the translation into all EU languages (and Norwegian and Icelandic) by the end of April 2019.