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news.US-based pharmaceutical firm SteadyMed Therapeutics has submitted an application to the US Food and Drug Administration (FDA) seeking orphan drug designation for its lead drug product candidate, Trevyent, to treat pulmonary arterial hypertension (PAH), a rare, progressive, life-threatening disease.
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The agency has acknowledged receipt of the application and will notify the company when the review process is completed.
If the FDA grants orphan drug designation, Trevyent would qualify for various development incentives such as tax credits, waiver of new drug application (NDA) submission fees, possibility for a priority review upon filing of its NDA submission, and potentially a 7-year period of marketing exclusivity after NDA approval is granted.
SteadyMed president and CEO Jonathan Rigby said: "SteadyMed continues to execute on our strategic goals including our submission of this request for orphan drug designation.
"We look forward to a decision from the FDA as we continue to drive to submission of an NDA for Trevyent in the first quarter of 2016."
Around 30,000 patients in the US are currently diagnosed with PAH, which can eventually lead to heart failure and premature death.
Trevyent is a development stage drug product that combines the company’s PatchPump technology with treprostinil, a vasodilatory prostacyclin analogue to treat PAH.