Actavis plc’s (ACT) new drug application (NDA) for its antibiotic candidate, ceftazidime-avibactam, has been accepted for review by the FDA. Actavis is looking to get ceftazidime-avibactam approved for the treatment of patients with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), including those caused by multi-drug resistant gram-negative bacterial pathogens.
A response from the FDA regarding the approval status of the candidate should be out in the first quarter of 2015. Meanwhile, the company intends to file a supplemental new drug application (sNDA) to the FDA based on the single pooled dataset of two pivotal phase III studies (RECLAIM-1 and -2) evaluating ceftazidime-avibactam as a treatment for adult patients with cIAI.
Ceftazidime-avibactam was granted qualified infectious disease product (QIDP) status by the FDA in Mar 2013 for cIAI, cUTI and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP).
The QIDP designation will provide priority review, eligibility for the FDA’s fast track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.
We remind investors that ceftazidime-avibactam became a part of Actavis’ portfolio through its recent acquisition of Forest Laboratories.
Ceftazidime-avibactam is being developed by Actavis in collaboration with AstraZeneca (AZN). While Forest Labs has commercialization rights in North America, rest of the world commercialization rights are with AstraZeneca.
We are pleased with Actavis’ progress with its branded product portfolio, following its acquisition of Forest Laboratories. The company recently received priority review status for eluxadoline for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant irritable bowel syndrome (IBS-D).
We expect investor focus to remain on pipeline updates.
Actavis is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Mallinckrodt plc (MNK) and Akorn, Inc. (AKRX). Both hold a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment