MDX-124 receives Orphan Designation from the EMA for the Treatment of Pancreatic Cancer

1 March 2023

Medannex’s first-in-class therapy MDX-124 has received Orphan Medicinal Product positive opinion from the European Medicines Agency (EMA) for the treatment of pancreatic cancer.

This acknowledges the unmet medical need in this area, and the significant potential of MDX-124 to improve treatment options for pancreatic cancer. The EMA’s decision was driven by compelling non-clinical data showing inhibition of tumour growth and improved survival, as well as powerful synergy between MDX-124 and current standard of care treatments.

Pancreatic cancer is a chronically debilitating and life-threatening condition associated with markedly reduced life expectancy.

The designation provides Medannex with special incentives in the EU, including regulatory fee reductions and 10 years of marketing exclusivity once MDX-124 gains approval.

Medannex CEO Ian Abercrombie said: ‘We’re delighted to receive this positive opinion from the EMA, a further endorsement of the potential of MDX-124 as a powerful new oncology therapy. This brings us another step closer to our goal of providing new treatment options for people living with cancer.’

The Orphan Medicinal Product designation has been subsequently granted by the European Commission and can be viewed in the EU Orphan Register here: