SteadyMed’s New Drug Application (NDA) for Trevyent to treat Pulmonary Arterial Hypertension (PAH) has been rejected by the U.S. Food and Drug Administration (FDA). The company announced they have received a Refuse to File letter from the regulatory agency about their NDA submission.
A Refuse to File letter means the FDA, based on a preliminary review, has determined that the NDA is lacking in some details and will not review the application in its current state.
PAH, as the name implies, consists of high blood pressure being present in the pulmonary artery. Symptoms of PAH are similar to those observed with more common heart and lung conditions. As a result, it may not be diagnosed unless symptoms are more severe. There are currently several drugs on the market for treating PAH, including Uptravi (selexipag), Opsumit (macitentan), Adempas (riociguat), and Tyvaso (treprostinil).That latter drug, is in an inhalable formulation while SteadyMed’s Trevyent is a sterile, pre-filled, pre-programmed, single use disposable infusion system capable of delivering treprostinil subcutaneously or intravenously.
According to the company, the FDA informed them that further information on certain device specifications and performance testing is still needed as well as additional design verification and validation testing on the final, to-be-marketed Trevyent product.
The company plans to request a Type A meeting with the FDA to gain further clarification but is optimistic it can meet the additional requirements asked by the FDA without the need for more studies.
“We believe that the issues raised in the letter from FDA can be sufficiently addressed. 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,” said Jonathan M. N. Rigby, President and CEO of SteadyMed. “We believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care, and remain committed to bringing the product to patients in need.”
Trevyent is a sterile, pre-filled, pre-programmed, single use disposable infusion system capable of delivering treprostinil subcutaneously or intravenously.
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