Iclaprim regulatory update

FDA granted Fast Track designation to IV iclaprim from Motif Bio to treat acute bacterial skin and skin structure infections (ABSSSIs) and hospital-acquired bacterial pneumonia (HABP). This half, Motif plans to start Phase III trials of iclaprim to treat ABSSSIs. The broad-spectrum antibiotic that inhibits dihydrofolate reductase (DHFR) has Qualified Infectious Disease Product (QIDP) designation from FDA for both indications.

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. ...