Dive Brief:
- The Food and Drug Administration on Friday approved a new combination antibiotic developed by AbbVie and Pfizer for tough-to-treat bacterial infections.
- The drug, named Emblaveo, is cleared for use alongside the antibiotic metronidazole in adults who have either limited or no other available options to treat their complicated intra-abdominal infections. The drug is indicated for use even if those infections are caused by so-called gram-negative bacteria, like E. coli or Klebsiella pneumoniae.
- Gram-negative bacterial infections are difficult to control and seen as a public health threat because of their ability to thwart available treatment. The World Health Organization notes antimicrobial resistance is making infections harder to treat and medical procedures riskier. One estimate holds that antibiotic resistance could lead to more than 39 million deaths globally by 2050.
Dive Insight:
The FDA has long prioritized and incentivized research into new antibiotics. And though drugmakers still struggle to sell them due to well-established financial challenges, there have been a series of drug approvals in recent years.
Emblaveo has two components. One is the antibiotic aztreonam and the other is avibactam, which helps aztreonam fight bacteria that can resist treatment. Its approval was supported by data from a Phase 3 study testing the combination against the antibiotic meropenem in complicated intra-abdominal infections or hospital-acquired pneumonia. Study results published in The Lancet in February showed Emblaveo led to similar cure rates. Mortality rates were also similar between study groups.
According to AbbVie, Emblaveo is the first combination therapy of its kind approved for use against these types of tough-to-treat infections. The drug was cleared last year in Europe for people with multidrug-resistant infections and limited treatment options.
Abbvie holds drug rights in the U.S. and Canada, while Pfizer owns commercialization rights elsewhere.
The drug is expected to be available in the U.S. by the third quarter.
