Motif Bio receives CRL from FDA regarding NDA for iclaprim
Motif Bio announced that the company has received a Complete Response Letter, or CRL, from the FDA regarding the New Drug Application, or NDA, for iclaprim for the treatment of acute bacterial skin and skin structure infections, or ABSSSI. The CRL states that the FDA cannot approve the NDA in its present form and indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved. Motif Bio plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies. Graham Lumsden, CEO of Motif Bio, said: "We are disappointed for patients and providers seeking an alternative antibiotic to treat ABSSSI. We intend to request a meeting with the FDA, which typically should occur within approximately 30-45 days, to discuss the CRL. We look forward to working with the Agency to discuss options to advance iclaprim towards approval."