Eisai’s amatuximab gains orphan status in EU for malignant mesothelioma

The investigational monoclonal antibody amatuximab (development code: MORAb-009), has today been granted orphan drug designation (ODD) for the treatment of malignant mesothelioma by the European Commission, reports Japanese drug major Eisai (TYO: 4532).

“Eisai is dedicated to providing new options for people with difficult-to-treat diseases. The ODD for amatuximab highlights the need for new effective treatments for people with malignant mesothelioma and the potential for this investigational drug,” says Gary Hendler, president and chief executive of Eisai EMEA & Russia.

Malignant mesothelioma is a rare form of cancer that affects an estimated 1 in 50,000 (0.2/10,000) people per year in Europe. Studies have shown highest incidence in the UK and Ireland and lowest in Eastern Europe.  This aggressive form of lung cancer is caused by asbestos exposure and despite a dramatic decrease in asbestos use since the mid-1970s its incidence is expected to increase.