MSD is gearing up to file antibiotic Zerbaxa on both sides of the Atlantic for certain forms of pneumonia on the success of a late-stage trial backing its safety and efficacy.
The Phase III ASPECT-NP trial randomised 726 adults with either ventilated hospital-acquired bacterial pneumonia (HABP) or ventilated-associated bacterial pneumonia (VABP) to receive either Zerbaxa or meropenem against Pseudomonas aeruginosa, one of the bacterial strains that accounts for the majority of HABP/VABP infections.
The trial met its pre-specified endpoints in showing that Zerbaxa was non-inferior to meropenem in day 28 all-cause mortality and in clinical cure rate at the test-of-cure visit.
Based on these results, the company said it plans to submit supplemental new drug applications seeking regulatory approval of Zerbaxa for this new indication in the US and EU.
Given the high prevalence of multidrug-resistant Pseudomonas aeruginosa in the intensive care setting, new safe and broadly effective treatment options are needed for critically ill patients requiring treatment.
HABP and VABP are serious and life-threatening hospital related pulmonary infections, especially in patients with severe underlying medical conditions,” said Dr Roy Baynes, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.
“The results from the ASPECT-NP study demonstrate the potential role of Zerbaxa for the treatment of patients with HABP and VABP.”
Zerbaxa, which consists of the cephalosporin antibiotic ceftolozane and the beta-lactamase inhibitor tazobactam, was approved to treat adults with complicated intra-abdominal infections and complicated urinary tract infections in 2014.