AstraZeneca: CHMP Issues Positive Opinion For CAZ AVI

(RTTNews) - British drug maker AstraZeneca plc (AZN.L, AZN) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.

CAZ AVI is being jointly developed by AstraZeneca and Allergan plc (AGN) to treat a broad range of Gram-negative bacterial infections that are increasingly resistant to antibiotics, including multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing Enterobacteriaceae.

Increasing antibiotic resistance in Gram-negative bacteria is a growing public health concern because of the limited new treatment options for these serious infections. In Europe, Gram-negative bacteria are responsible for two thirds of the annually reported 25,000 deaths resulting from antimicrobial resistance.

The CHMP's positive opinion on CAZ AVI will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union or EU. The final decision by the EC is expected in the coming months and will be applicable to all 28 EU member countries plus Iceland, Norway and Liechtenstein.