SteadyMed Gets Orphan Drug Status For Trevyent In PAH

(RTTNews) - SteadyMed Ltd. (STDY), a specialty pharmaceutical company, announced the granting of Orphan Drug Designation from the U.S. Food and Drug Administration for its lead product development candidate Trevyent, for the treatment of pulmonary arterial hypertension or PAH, a rare form of blood pressure.

Trevyent is a combination of the company's PatchPump and treprostinil. According to the company, the granting of Orphan Drug Designation demonstrates that Trevyent has the potential for clinical superiority over existing treprostinil PAH treatments such as Remodulin, the market leading parenteral prostacyclin sold by United Therapeutics.

The FDA's Orphan Drug Designation program grants orphan status to drugs intended for the treatment of rare disorders affecting fewer than 200,000 people in the U.S. The designation means Trevyent may be eligible for certain benefits, including tax credits for clinical research costs, and a waiver of the Prescription Drug User Fee Act filing fees.

Trevyent may also receive a seven-year period of U.S. marketing exclusivity upon approval, which may potentially block other treprostinil based products from coming to market.