AbbVie says FDA approves Emblaveo in combination with metronidazole in adults

AbbVie (ABBV) announced that the U.S. Food and Drug Administration has approved EMBLAVEO, as the first and only fixed-dose, intravenous, monobactam/beta-lactamase inhibitor combination antibiotic. It is approved in combination with metronidazole, for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections, including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. Gram-negative bacterial infections are among the most challenging for healthcare professionals to control due to high antimicrobial resistance. In 2019, the FDA granted Qualified Infectious Disease Product Designation and Fast Track Designation for EMBLAVEO. The QIDP Designation provides certain incentives for the development of new antibiotics, including priority review and eligibility for the FDA’s Fast Track Designation, and a five-year regulatory exclusivity extension.8 The Fast Track Designation is designed to facilitate the development of and accelerate the review of drugs to treat serious conditions that do not have sufficient treatment options. EMBLAVEO will be available for commercial use in the U.S. in Q3 2025.