AbbVie: FDA Approves Emblaveo - Metronidazole Combination For Complicated Intra-Abdominal Infections

(RTTNews) - AbbVie (ABBV) announced the U.S. Food and Drug Administration approval of Emblaveo (aztreonam and avibactam). This marks the first fixed-dose, intravenous monobactam/ Beta -lactamase inhibitor combination antibiotic. In combination with metronidazole, Emblaveo is approved for patients aged 18 and older who have limited or no alternative options for treating complicated intra-abdominal infections (cIAI). It is effective against several susceptible Gram-negative microorganisms, including Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens.

According to the company, Emblaveo will be available for commercial use in the U.S. in third quarter 2025.

Emblaveo was jointly developed with Pfizer. AbbVie holds the rights to commercialize the therapy in the U.S. and Canada, with Pfizer responsible for commercialization in all other areas.

In 2019, the FDA granted Qualified Infectious Disease Product (QIDP) 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. 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.

ABBV closed Friday's regular trading at $190.60 down $2.37 or 1.23%. But in the after-hours trading, the stock gained $0.16 or 0.08%.

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