RE: The Future7 May 2020 17:45
he FDA has refused to approve the Company's Iclaprim for the proposed treatment of acute bacterial skin and skin structure infections (ABSSSI), and the Complete Response Letter issued states that additional data are needed to further evaluate the drug candidate's risk for liver toxicity before it could be approved.
This is not the first time that Iclaprim has been rejected by the FDA.
In 2009, when Iclaprim was proposed for the treatment of complicated skin and skin structure infections (cSSSI), the FDA indicated that additional clinical data are required to demonstrate efficacy, and refused to approve it. Iclaprim was under the aegis of Arpida, a Swiss company, then. Motif Bio acquired the rights to Iclaprim from Arpida in 2015.