FDA provides complete response for application for CEM 101 (solithromycin) in community-acquired bacterial pneumonia- Cempra

Cempra has received a Complete Response Letter (CRL) from the FDA relating to the company�s new drug applications (NDAs) for oral and intravenous CEM 101 (solithromycin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults. The CRL states that the FDA cannot approve the NDAs in their present form and notes that additional clinical safety information and the satisfactory resolution of manufacturing facility inspection deficiencies are required before the NDAs may be approved. The FDA did not request any further information on solithromycin efficacy for CABP in the CRL.

Based on their review of the NDAs, the CRL stated that the FDA determined the risk of hepatotoxicity had not been adequately characterized. The FDA noted the size of the safety database is limited to 920 patients who received solithromycin at the proposed dose and duration, and is too small to adequately characterize the nature and frequency of serious hepatic adverse effects. To address this deficiency, the FDA is recommending a comparative study to evaluate the safety of solithromycin in patients with CABP. Specifically, the CRL recommends that Cempra consider a study of approximately 9,000 patients exposed to solithromycin to enable exclusion of serious drug induced liver injury events occurring at a rate of approximately 1:3000 with a 95 percent probability.