Merck wins USFDA approval for antibiotic Zerbaxa to treat pneumonia
The approval is based on the treatment's late-stage trial results, which showed that Merck's drug, Zerbaxa, was as effective as another antibacterial drug.
New Delhi: The U.S. Food and Drug Administration said on Monday it approved expanded use of Merck & Co Inc's antibiotic to treat hospital-acquired pneumonia in patients 18 years and older.
The approval is based on the treatment's late-stage trial results, which showed that Merck's drug, Zerbaxa, was as effective as another antibacterial drug.
Hospital-acquired pneumonia occurs in patients at least two to three days after being admitted or in those who are on mechanical breathing machines and have life-threatening lung infections with high mortality rates.
These infections are typically treated using antibiotics, but the growing problem of antibiotic resistance has rendered some of the most commonly prescribed treatments ineffective.
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While the U.S. FDA has been pushing for newer versions of antibiotics, drugmakers have shied away from developing the treatments, as combating antimicrobial-resistant pathogens, popularly known as superbugs, becomes increasingly challenging.
At least 2 million people in the United States develop serious infections from antibiotic-resistant bacteria, resulting in nearly 23,000 deaths annually, according to the Centers for Disease Control and Prevention.
Zerbaxa, which was previously approved for treating complicated urinary tract infections and intra-abdominal infections, was added to Merck's drug portfolio through its buyout of antibiotics maker Cubist Pharmaceuticals.
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