FDA Issues Complete Response Letter Rejecting Iclaprim Approval for ABSSSI

Abscess on hand
Abscess on hand
The NDA included data from the Phase 3 REVIVE-1 and REVIVE-2 trials.

Motif Bio announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Iclaprim is an investigational diaminopyrimidine antibiotic with a targeted Gram-positive spectrum of activity and a distinct mechanism of action demonstrated by rapid bactericidal activity in vitro; it works by inhibiting the dihydrofolate reductase (DHFR) enzyme. Clinical data has indicated that the drug exhibits a low propensity for resistance development as well as a favorable tolerability profile. In clinical trials, iclaprim was administered intravenously at a fixed dose; no dosage adjustments were needed in patients with renal impairment or obesity.

In the CRL, the FDA stated the NDA could not be approved in its current form and that additional data were required to further evaluate the risk for hepatotoxicity before iclaprim could be approved.

Iclaprim has previously received Qualified Infectious Disease Product (QIDP) designation and a Fast Track status by the FDA for the treatment of ABSSSI. The Company plans to request a meeting with the FDA to discuss potential options to address the CRL.

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