Actavis plc (ACT) announced that the FDA’s Anti-Infective Drugs Advisory Committee has recommended the approval of the company’s New Drug Application (NDA) for ceftazidime-avibactam. Actavis is looking to get ceftazidime-avibactam approved 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.
However, the committee voted against the approval of the combination for hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) and bacteremia. The company intends to work closely with the FDA regarding the data required that would facilitate approval.
Actavis expects a response from the FDA regarding the approval status of the candidate in the first quarter of 2015.
We note that ceftazidime-avibactam is being developed by Actavis in collaboration with AstraZeneca (AZN). While Actavis has commercialization rights in North America, rest of the world commercialization rights are with AstraZeneca.
We are pleased with the panel’s voting in favor of approving ceftazidime-avibactam – chances of gaining approval look high.
We note that Cubist Pharmaceuticals’ (CBST) Zerbaxa (ceftolozane/tazobactam) is under priority review in the U.S. with a decision expected by Dec 21, 2014, for treating complicated urinary tract and intra-abdominal infections.
We are pleased with Actavis’ efforts to build its infectious disease portfolio. In keeping with this target, Actavis acquired Durata Therapeutics in November this year. The acquisition added Dalvance – the first and only IV antibiotic for acute bacterial skin and skin structure infections (ABSSSI) – to its infectious disease portfolio.
Actavis currently carries a Zacks Rank #2 (Hold). A better-ranked stock in the health care sector is Akorn, Inc. (AKRX) carrying a Zacks Rank #1 (Strong Buy).
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