Orion’s cancer drug prototype received orphan drug status from the European Medicines Agency

Pharmaceutical company Orion’s The ODM-212 molecule has been granted orphan drug status by the European Commission for the treatment of malignant mesothelioma.

With the orphan drug status granted to ODM-212, Orion is entitled to, among other things, protocol assistance, discounts on certain official fees, and a maximum of ten years of exclusivity on the market after the marketing authorization has been granted. Orphan drug status does not shorten the drug’s development time or official evaluation, nor does it give the drug special advantages in the official evaluation or approval process.

The European Medicines Agency grants orphan drug status to drugs that are intended for the treatment, prevention or diagnosis of life-threatening or chronically disabling rare diseases.

Mesothelioma is a rare and difficult to treat cancer. The US Food and Drug Administration FDA has previously granted orphan drug status to Orion’s ODM-212 for the treatment of mesothelioma.

ODM-212 is an oral small molecule pan-TEAD inhibitor developed by Orion Pharma and is currently being tested in a Phase 2 clinical trial in patients with either malignant pleural mesothelioma, epithelioid hemangioendothelioma, or another solid tumor and Hippo signaling pathway dysfunction.

The disease of the patients included in the study progresses despite the established treatment and they have no other standard treatment options left. Global research is conducted in leading cancer centers in the United States and Europe.