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Motif Bio seeks talks with FDA after iclaprim setback

The Food & Drug Administration has requested more data on the company's antibiotic
Motif Bio seeks talks with FDA after iclaprim setback
It could take up to six weeks before the Motif team can address the issues raised by the regulator

Motif Bio Plc (LON:MTFB, NASDAQ:MFTB) said it has requested a meeting with the Food & Drug Administration after the US watchdog said it wouldn’t be giving the regulatory green light to the company’s antibiotic, iclaprim.

In what’s called a complete response letter, the FDA indicated additional data would be required “to further evaluate the risk for liver toxicity” before granting approval.

READ: Motif Bio to present positive iclaprim drug data in the US this week

Motif, which developed the treatment for acute bacterial skin and skin structure infections, said it is keen to “to discuss potential options to address the deficiencies”. According to chief executive Graham Lumsden, his team may have to wait between 30-45 days before having the opportunity to do so.

"We look forward to working with the agency to discuss options to advance iclaprim towards approval," he said.

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Motif Bio PLC Timeline

May 07 2019

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