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HERZLIYA, Israel — The Food and Drug Administration has given orphan drug designation to an investigational treatment for multiple myeloma, a blood cell cancer, that soon will enter mid-stage development.
XTL announced that the FDA had granted the designation to its recombinant human erythropoietin, or rHuEPO drug, for which the company soon will start phase-2 clinical trials.
The FDA gives orphan drug designation to treatments for diseases that affect fewer than 200,000 people in the United States per year.
While an orphan drug still must undergo the agency’s standard regulatory approval procedures, the designation entitles it to extended market exclusivity periods, tax credits for research and development expenses and exemptions from payment of commissions to the FDA.