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.