Posted by Michael Wonder on 16 Jan 2019
European Medicines Agency validates Oasmia Pharmaceutical's application to add efficacy data to the approved Apealea product information
15 January 2019 - Oasmia Pharmaceutical today announce that the EMA has validated a type II variation application to add efficacy data to the Apealea product information.
Validation of the application confirms that the submission is complete and that the EMA assessment process begins. Based on the EMAs procedural timelines, Oasmia anticipates an opinion from the CHMP by end of Q1 or beginning of Q2 2019.
The application is based on subpopulation data (n=599) from the OAS-07OVA study and aims to provide treating physicians with efficacy data for Apealea in combination with carboplatin for the approved indication; adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.
