Actavis has announced that the Anti-Infective Drugs Advisory Committee is recommending that the U.S. FDA approve their New Drug Application for ceftazidime-avibactam, which is an investigational antibiotic under development to treat hospitalized patients for complicated intra-abdominal infections and urinary tract infections, when limited or no other treatment options are available.
Connecticut Health Policy Project Consumer representative Ellen Andrews, PhD, comments “[That] this drug works is scientifically plausible. That it will stay the course, I think, is a bit more problematic. I think that the long-term follow-up for assessing emergence of resistance with the use of this compound in clinical practice is very important.”
“We are pleased with the committee’s positive recommendation for ceftazidime-avibactam. It reinforces our belief in the safety and efficacy of the compound and its potential to address significant unmet needs as a new treatment option for patients with serious and life-threatening infections,” comments Actavis’ Global Brands Research and Development senior vice president, David Nicholson. “As public health officials continue to sound the alarm on antibiotic-resistant infections, Actavis remains committed to advancing the ceftazidime-avibactam clinical development program, including for the combination of hospital acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP), and bacteremia, and working closely with the FDA as it completes its review of our New Drug Application.”
Speaking of which, ceftazidime-avibactam acts to inhibit a wide range of beat-lactamases. This includes some that fall under Class A and some that fall under Class D beta lactamases which could be encountered in a hospital setting and which are often involved with some of the more serious cIAI and cUTI infections.
But the Advisory Committee’s recommendation is, of course, not binding so the FDA can still opt to not approve the New Drug Application, which they will deliberate about until sometime in the next few months.
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