UK-based Motif Bio's skin disorder drug, iclaprim, has been denied approval by the US Food & Drug Administration (FDA) it was reported on Friday.
The product is intended for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
In the complete response letter, the US FDA stated that it cannot approve the company's New Drug Application (NDA) for the product in its present form. The regulator indicated to the company that additional data was required in the NDA to further evaluate the risk for liver toxicity prior to the drug's approval. The company stated that it will seek a meeting with the FDA as early as possible to explore potential options to address the shortcomings.
Iclaprim's NDA filed with the FDA included data from the REVIVE-1 and REVIVE-2 phase 3 trials in patients with ABSSSI. The product is a gram-positive investigational antibiotic. Its approval for the ABSSSI indication would make it eligible for 10 years of US market exclusivity.
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