FDA approves Actavis' QIDP-designated antibiotic combo
- The FDA on Wednesday approved Actavis/Forest Labs' new antibiotic combo Avycaz (ceftazidime-avibactam).
- Avycaz is approved for the treatment of adults with complicated intra-abdominal infections (cIAI) alongside treatment with metronidazole. It is also approved for adults with complicated urinary tract infections (cUTI) and kidney infections who don't have access to other effective treatments.
- The new antibacterial is designated as a Qualified Infectious Disease Product (QIDP). This is the fifth QIDP-designated antibiotic approved by the FDA.
FDA spokespeople emphasized that this drug should only be reserved for patients with a truly unmet need who have no other recourse.
"The FDA is committed to making therapies available to treat patients with unmet medical need," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. "It is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection."
Actavis has been working hard to shore up its infectious disease franchise. Last year, the company struck a deal worth as much as $675 million with Durata Therapeutics that gave Actavis access to the antibiotic Dalvance (dalbavacin), which was the first QIDP-designated product to be approved by the FDA.
Since both Dalvance and Avycaz were approved under the FDA's Generating Antibiotic Incentives Now (GAIN), the drugs have an extra five-year exclusivity period.