Cempra's (CEMP) Solithromycin Receives EMA Valiation for Marketing App

August 23, 2016 7:31 AM EDT

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Cempra (NASDAQ: CEMP) 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.

“With increasing failure rates of primary antibiotic therapy and increasing hospitalization rates due to CABP in the EU, there is an urgent need for new safe and effective oral and intravenous antibiotic therapies,” said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.

“The validation of Cempra’s MAA brings solithromycin another step closer to meeting this need in the EU and we look forward to continuing to work closely with the EMA through the review process,” Fernandes added.

If approved, solithromycin would be the first new oral and IV antibiotic available in the EU in more than 15 years. According to the European Respiratory Society (ERS), more than 3,000,000 cases of community-acquired pneumonia are diagnosed each year in the EU, resulting in approximately 1,000,000 hospitalizations annually. The ERS notes that antibiotic resistance is one of the major threats undermining the treatment of respiratory infections.

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