FDA Approves Actavis’ Antiobiotic For Superbugs

Actavis Plc’s antibiotic Avycaz was approved for use by the United States Food and Drug Administration on Wednesday. The drug is meant for drug-resistant bacteria known as super bugs. Avycaz is used to treat urinary tract infections, and in combination with generic antibiotic metronidazole, it is used to treat adults with complicated intra abdominal infections.

Seven patients were infected with a potentially deadly, drug-resistant strain of Enterobacteriaceae bacteria and more than a 100 people may have been exposed to it, the University of California Los Angeles Health System reported. Concerns about superbugs have increased since then. There is room for multiple players in the superbugs area, and a number of companies, including Roche Holdings AG, Tetraphase Pharmaceuticals Inc, Achaogen Inc and Cempra Inc, are developing drugs for a variety of superbugs.

Actavis estimated peak sales of about $250 million to $500 million for the drug. Avycaz, which is co-developed with AstraZeneca Plc, is a combination of a previously approved antibacterial drug called ceftazidime as well as avibactam, which helps to extend bacterial resistance. The drug Avycaz will be available in the second quarter of 2015.

After decades of low investment in antibiotics, pharmaceutical companies are once again focusing on these drugs because of the spread of superbugs. The World Health Organisation warned in April of "a post-antibiotic era" in which common infections would once again become killers, Reuters reports.

Avycaz is also useful in treating kidney infections for which there are few other options. According to ABC News, it is the fifth drug that has been given an expedited review by the FDA due to the superbug scare. Its most common side effects include vomiting, nausea, constipation and anxiety. It will be distributed by Forest Laboratories, which was acquired by Dublin-based Actavis in the summer of 2014.

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