The European Commission and the European Medicines Agency have issued orphan drug designation to PROLOR Biotech's hGH-CTP.
The longer-acting version of human growth hormone, hGH-CTP, is being developed to treat growth hormone deficiency.
PROLOR CEO Dr. Abraham Havron said, "By reducing the dosing frequency to just one injection every week, our longer-acting human growth hormone has the potential to improve the lives of the many individuals with growth hormone deficiency."
Up on the launch of the product, PROLOR will have 10 year marketing exclusivity in Europe for longer-acting human growth hormone products.
The hGH-CTP, first growth hormone product to receive orphan status, was safe, well tolerated and demonstrated potential to be administered once-weekly in the Phase II studies in growth hormone-deficient adults.