StockMarketWire.com - Motif Bio announced the completion of its rolling submission of a new drug application (NDA) to the US Food & Drug Administration (FDA) for iclaprim.

Iclaprim is a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

CEO Graham Lumsden commented: "The NDA submission for iclaprim is a major milestone for Motif Bio.

"Our team of experts has worked tirelessly to achieve this important goal.

"We look forward to working with the FDA with the goal of bringing this antibiotic candidate to patients as expeditiously as possible."

Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with fast track designation.

On acceptance of the filing of the NDA by the FDA, iclaprim will receive priority review, a review period of six months instead of the standard ten months.

If iclaprim is approved as a new chemical entity with QIDP designation, it will be eligible for ten years of market exclusivity in the US starting from the date of approval.




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