Protagonist's Hepcidin Mimetic Candidate PTG-300 Receives Fast Track Designation from the U.S. Food and Drug Administration for Development in the Treatment of Polycythemia Vera
"Fast Track designation reflects the potential for PTG-300 to improve upon the treatments that are currently available for patients with polycythemia vera, and provides opportunities to substantially accelerate clinical development," commented
The FDA Fast Track Program is designed to facilitate the development and expedite the review of new therapeutics that are intended to treat serious conditions and that demonstrate the potential to address unmet medical needs. Drugs that receive this designation benefit from more frequent interactions and meetings with the FDA and potential pathways for expedited approval.
A Phase 2 study of PTG-300 in patients with polycythemia vera is currently enrolling subjects. Additional information is available at http://ptg300pvstudy.com/.
About Polycythemia Vera
Polycythemia vera is a myeloproliferative neoplasm characterized primarily by the increased production of red blood cells. Well-established treatment guidelines focus on maintaining hematocrit levels continuously below 45 percent to reduce the risk of thrombotic events. Unfortunately, current treatment options are unable to maintain hematocrit to below the 45 percent target for many patients and may be associated with serious side effects. There are an estimated 100,000 patients with polycythemia vera in the
Protagonist is headquartered in
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