Allergan’s Phase 3 Studies of UTI Drug Support FDA Priority Review

Allergan said last week that results from two Phase 3 studies evaluating Avycaz in hospitalized adults with complicated urinary tract infections, including pyelonephritis, affirm the drug’s safety and efficacy.

Avycaz (eftazidime-avibactam) was approved by the FDA in February for patients who have limited or no alternative treatment options, based on Phase 2 and supporting in vitro data.  In addition to getting a priority review, the drug was designated by the agency as a qualified infectious disease product — a designation given to antibacterial products to treat serious or life-threatening infections. The QIDP designation qualifies the drug for five years of marketing exclusivity beyond the five-year exclusivity period provided by priority review.  

Allergan plans to file an sNDA by the end of the year to support Avycaz’s use as a treatment option for a wide range of patients who suffer serious and life-threatening complicated urinary tract infections.

Currently under review by the European Medicines Agency, Avycaz is being co-developed with AstraZeneca. Allergan holds U.S. rights to the therapy, while AZ has rights to the rest of the world.

Separately, Allergan said last week that the FDA has approved an sNDA to update the label for Teflaro (ceftaroline fosamil), which was approved in 2010 to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Allergan added the drug to its portfolio in 2014 when it acquired Forest Laboratories. — Kellen Owings