SteadyMed Ltd has received an Orphan Drug Designation from US FDA for its lead product development candidate, Trevyent, a combination of the company’s PatchPump and treprostinil, for the treatment of pulmonary arterial hypertension (PAH).
The granting of Orphan Drug Designation demonstrates that Trevyent has the potential for clinical superiority over existing treprostinil PAH treatments, according to SteadyMed.
“Both parenteral and inhaled treprostinil have previously been granted Orphan Drug Designation so I believe that this achievement supports our expectation that Trevyent, if approved, may offer a meaningful contribution to patient care compared to other oral, inhaled and parenteral prostacyclin treatments for PAH,” said Jonathan Rigby, president and CEO of SteadyMed.
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