Iclaprim regulatory update

FDA granted Qualified Infectious Disease Product (QIDP) designation to iclaprim from Motif to treat hospital-acquired bacterial pneumonia (HABP) and acute bacterial skin and skin structure infections (ABSSSIs). Motif has not yet determined a development timeline in HABP but plans to start Phase III trials of iclaprim to treat ABSSSIs this half.

FDA issued a complete response letter in 2009 for iclaprim to treat complicated skin and skin structure infections (cSSSIs), when the compound belonged to Arpida Ltd. That company also withdrew an MAA for iclaprim to treat cSSSIs after a negative opinion from EMA’s CHMP. ...