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.
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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