Pfizer (NYSE:PFE) said on Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), has adopted a positive opinion for its novel antibiotic combination for the treatment of patients with multidrug-resistant infections and limited treatment options.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Emblaveo, intended for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia, and infections due to aerobic Gram-negative organisms in patients with limited treatment options.
Emblaveo, a fixed-dose combination of two active substances (aztreonam and avibactam), was reviewed under the agency’s accelerated assessment program. It will be available to be given by infusion into a vein.
EMA’s recommendation is based on the safety and efficacy data already available for each active substance and the results of two late-stage randomized trials submitted by the drugmaker. The studies were not designed to demonstrate efficacy but do provide safety and complementary data for the combination.
The opinion will now be sent to the European Commission (EC) for the adoption of a decision on an EU-wide marketing authorization.