Merck to file for new use for antibiotic Zerbaxa
Merck & Co is to apply for a new indication for its antibiotic Zerbaxa (ceftolozane+tazobactam), after it hit target in a new clinical trial.
The US-based pharma said it will apply to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) to use Zerbaxa at a different dose for adults with either ventilated hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).
According to US Merck a trial powered to show the drug is no less effective than the existing standard of care met primary goals of all-cause mortality, and in clinical cure rate at the test-of-cure visit.
Zerbaxa is approved in the US for adults with complicated urinary tract infections, including pyelonephritis, caused by certain gram-negative microorganisms.
It is also indicated in combination with metronidazole in adult patients for the treatment of complicated intra-abdominal infections caused by certain gram-negative and gram-positive microorganisms.
As well as filing the findings with regulators, Merck plans to submit results from the study for presentation at a future scientific conference.
Dr Roy Baynes, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said: “HABP and VABP are serious and life-threatening hospital related pulmonary infections, especially in patients with severe underlying medical conditions.
“The results from the ASPECT-NP study demonstrate the potential role of Zerbaxa for the treatment of patients with HABP and VABP.”
ASPECT-NP is a prospective randomised, double-blind, multicentre, non-inferiority, phase 3 study which assessed the safety and efficacy of Zerbaxa compared with meropenem in 726 adult patients diagnosed with either ventilated HABP or VABP requiring intravenous antibiotic therapy.
Zerbaxa was administered in an investigational 3g dose compared with meropenem 1g, each given intravenously every eight hours for 8 to 14 days, or for 14 days for Pseudomonas aeruginosa infection. Meropenem is an approved broad-spectrum injectable antibiotic widely used to treat serious infections.
Merck came to Zerbaxa through its $9.5 billion acquisition of Cubist five years ago – but despite the potential new indication sales are a disappointment and well below the blockbuster level of sales expected at the time of acquisition.
Even though it’s vital to have new antibiotics on the market in case bacteria become resistant to older drugs, doctors will always prescribe cheap old drugs first to save money, and to prevent bugs building resistance to the newer compounds.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.