New York-based Motif Bio PLC said the U.S. Food and Drug Administration has accepted and granted priority review to its new drug application seeking approval for iclaprim, an antibiotic for treating bacterial skin infections.
The regulator plans to make a decision on the application by Feb. 13, 2019.
The antibiotic is meant to treat acute bacterial skin and skin structure infections, an infection of the skin and associated soft tissues.
Motif's application is supported by the data from two late-stage clinical trials which showed the drug worked as well as the current standard of care vancomycin.
The drug may also be eligible for 10 years of market exclusivity in the U.S.