Arpida obtains FDA complete response letter for antibiotic drug

The FDA indicated in its letter that they cannot approve the application for iclaprim in its current form and that additional clinical data are required to demonstrate efficacy in order to gain approval.

In its letter to Arpida, the FDA stated the company’s new drug application (NDA) did not demonstrate the efficacy of iclaprim for treatment of complicated skin and skin structure infections (cSSSI) within an acceptable non-inferiority margin. The FDA requires additional data to assess the benefits and risks of iclaprim for cSSSI.

To address this deficiency, the FDA requests an additional study or studies to demonstrate effectiveness of iclaprim. An additional study showing non-inferiority of iclaprim to an approved comparator may be sufficient to meet this requirement, depending on the study results.

Moreover, the FDA raised questions related to the drug product, which Arpida believes can be rapidly addressed. In addition, the resubmission should provide updated safety data and labeling information.

Jurgen Raths, president and CEO of Arpida, said: After the negative recommendation of the advisory committee of last November, the FDA opinion comes as no surprise. We now aim to develop a viable road-map to approval in close consultation with the FDA.