Actinium Obtains Orphan Drug Designation in Europe

Actinium Pharmaceuticals (NYSEMKT:ATNM) received orphan drug designation for Actimab-A by the European Medicines Agency.
As quoted in the press release:

Actimab-A is intended to be used, upon approval, in patients newly diagnosed with Acute Myeloid Leukemia (AML) who are over the age of 60 that are ineligible for standard induction therapy. Actimab-A is currently in a multi-center Phase 2 clinical trial that will enroll 53 patients.

In order to qualify for orphan designation in the EU, a medicine must be intended to treat a disease that is life-threatening or chronically debilitating. Also, no satisfactory treatment of the disease can be authorized, or, if a satisfactory treatment exists, the medicine must be of significant benefit to those affected by the disease. The EMA grants orphan designation to rare diseases that are defined as life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in the EU. With an estimated 30 million people living in the EU this equates to approximately 250,000 people or less for each rare disease.

Click here to read the full press release.

Source: globenewswire.com