Cempra soars as FDA advisory panel vote finds solithromycin benefits outweigh risk

7 November 2016

A US Food and Drug Administration (FDA) advisory panel has found that the benefits of solithromycin, a potential treatment for community acquired bacterial pneumonia (CABP), outweigh the risks – but only just.

The 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.

Solithromycin was developed by antibiotics specialist Cempra (Nasdaq:CEMP) as a derivative of French pharma major Sanofi’s (Euronext: SAN) Ketek (telithromycin), a drug which has had its indications reduced and had boxed warnings added over safety concerns.

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