Clinigen has launched a Managed Access Program for Progenics Pharmaceuticals - an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer - in order to provide Azedra (iobenguane I 131) outside the United States.
The drug in question is a high-specific-activity radiotherapeutic agent, approved in the US for the treatment of adult and paediatric patients older than 12 with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
Azedra is currently not approved for any indication outside of the US, hence the aim for a Managed Access Program.
“Clinigen’s new partnership with Progenics aligns with our mission to deliver the right medicine to the right patient at the right time,” said James Winterman, senior vice president of unlicensed medicines, Clinigen.
He continued, “Through our global infrastructure and expertise in the supply of unlicensed medicines, eligible patients with pheochromocytomas and paragangliomas will now be able to gain access to this new medicine.”
Pheochromocytomas and paragangliomas are ultra-rare adrenal gland tumours, with approximately 55,000 new cases each year world-wide. Over a quarter of cases are genetically linked, and the tumours frequently secrete high levels of hormones that can lead to life-threatening high blood pressure, heart failure, and stroke.