FDA
12th December 2014

FDA advisory panel supports approval of Actavis’ ceftazidime-avibactam

Last Friday, the FDA’s Anti-Infective Drugs Advisory Committee recommended the approval of Actavis’ New Drug Application (NDA) for ceftazidime-avibactam for the treatment of  hospitalized patients.

FDA advisory panel supports approval of Actavis’ ceftazidime-avibactam

Last Friday, the FDA’s Anti-Infective Drugs Advisory Committee recommended the approval of Actavis’ New Drug Application (NDA) for ceftazidime-avibactam for the treatment of  hospitalized patients (when limited or no treatment options are available) for complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI) (including acute pyelonephritis) caused by gram-negative pathogens. The committee found the scientific and clinical evidence submitted by Cerexa (a wholly-owned subsidiary of Actavis) adequately demonstrated the safety and efficacy of ceftazidime-avibactam in the treatment of cIAI and cUTI.

Despite the support for approval in the above indications, the committee voted against the approval of the combination for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) and bacteremia.

Additionally, the panel raised concerns around labeling, particularly for patients with renal impairment.

Actavis intends to work closely with the FDA regarding the data required that would facilitate approval, and expects a response from the FDA regarding approval status in the first quarter of 2015.

David Nicholson, senior vice president, Global Brands R&D, Actavis stated, “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.”

The FDA is not obligated to follow the advice of its panels, but normally does so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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