The U.S. Food and Drug Administration (FDA) has declined SteadyMed Therapeutics‘ new drug application (NDA) for its Trevyent (treprostinil injection) therapy to treat pulmonary arterial hypertension (PAH).
SteadyMed, with offices in San Ramon, California, and in Israel, had submitted its NDA in July 2017. But the application was denied on Aug. 31 because it was incomplete. The FDA has requested further data on specifications and performance testing of SteadyMed’s PatchPump device. It also requires additional design verification and validation.
In PAH, constricted blood vessels linking the heart and lungs prevents blood from being easily pumped through the lungs. One of the most effective PAH treatments is prostacyclin, a vasodilator that prevents blood vessels from constricting and blood platelets from clumping. Treprostinil, a synthetic analogue of prostacyclin, is used to tret PAH.
SteadyMed’s Trevyent delivers treprostinil using PatchPump — a small, disposable, electronically controlled, pre-filled and pre-programmed drug delivery device. It can deliver treprostinil subcutaneously or intravenously, and gives patients audible and visual signals that the drug is being delivered.
SteadyMed said it would provide further guidance following a meeting with the FDA, which is to be scheduled soon.
“We believe that the issues raised in the letter from FDA can be sufficiently addressed,” SteadyMed President and CEO Jonathan M.N. Rigby said in a press release. “Our next step is to work with the FDA to address the open issues and identify a path to a successful resubmission and acceptance of our application.”
Rigby added: “We believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care.”
In January 2016, the FDA gave Trevyent an Orphan Drug Designation for the treatment of PAH. Earlier this year, SteadyMed received a U.S. patent for its PatchPump infusion system for injectable drugs, including Trevyent.