Liver toxicity concerns spike Motif Bio’s iclaprim filing

Discussion in 'Pharma/Biotech Companies - In the News' started by cafead, Feb 14, 2019 at 6:02 PM.

  1. cafead

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    via Motif Bio’s hope of adding to the antibiotic armamentarium for serious bacterial infections has just been dealt a blow by the FDA.

    The company says the regulator has rejected its marketing application for iclaprim as a treatment for acute bacterial skin and skin structure infections (ABSSSI) as it needs “additional data … to further evaluate the risk for liver toxicity before [it] can be approved.”

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