FDA grants fast track designation for Iclaprim

The Food and Drug Administration (FDA) has granted fast track designation for Motif Bio’s iclaprim intravenous (IV) drug to treat acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP)

The FDA's fast track programme is designed to aid the development and accelerate the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Graham Lumsden, chief executive officer at Motif, said: "This is excellent news for Motif and comes on the back of the QIDP designation for iclaprim in late July. This fast track designation means we will benefit from greater FDA support and that we remain on our Phase III development timeline."

The FDA has previously designated iclaprim for the treatment of ABSSSI and HABP as a Qualified Infectious Disease Product (QIDP).