FDA calls for more data on solithromycin

29 December 2016

Shares of US antibiotics developer Cempra (Nasdaq: CEMP) slumped 53.4% to $2.85 in early trading this morning, following news late Thursday of a significant delay in the development of its pneumonia drug candidate.

The US Food and Drug Administration issued a complete response letter (CRL) relating to the company’s New Drug Applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

The news comes as a bit of a surprise, given that just last month the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted by seven votes to six that the drug's potential efficacy carried greater weight than safety concerns surrounding solithromycin, including fears that the drug could raise liver enzyme levels.

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