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Motif Bio completes FDA submission for Iclaprim antibiotic

The AIM-listed bio-pharma company said Iclaprim had received Qualified Infectious Disease Product designation from the FDA together with Fast Track Designation
Antibiotics
If accepted by the FDA, Iclaprim will have a review period of six months rather than ten

Motif Bio Plc (LON:MTFB) has completed a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its new antibiotic Iclaprim.

The AIM-listed bio-pharma company said Iclaprim, a targeted, Gram-positive investigational antibiotic for the treatment of acute bacterial skin and skin structure infections, had received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track Designation.

WATCH: Motif Bio completes rolling submission of NDA for new antibiotic Iclaprim

The group added that upon acceptance of the filing of the NDA by the FDA, Iclaprim would 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 10 years of market exclusivity in the US starting from the date of approval.

The news follows an announcement earlier this week when Motif confirmed that Iclaprim was confirmed to be better tolerated and safer than a rival drug in two recent late-stage studies.

In early-morning trading Thursday, Motif Bio shares were up 1% at 32.7p.

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