EMA validates application (MAA) by Cempra for approval of solithromycin for the treatment of community-acquired bacterial pneumonia .

Cempra, Inc.has announced that the European Medicines Agency (EMA) has validated the company's marketing authorization application (MAA) seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP, also referred to as community-acquired pneumonia (CAP) in the EU). The EMA's validation of the MAA confirms that the submission is complete and formally starts the review process.

The EMA's Committee for Medicinal Products for Human Use (CHMP) will now begin their assessment of solithromycin through the centralized review procedure. If the CHMP review results in a positive opinion, the next step would be for the European Commission to grant marketing clearance for solithromycin, which would apply to all EU member states.