The US FDA has approved the experimental antibiotic Zerbaxa for the treatment of typical urinary tract infections and intra abdominal infections. The experimental antibiotic Zerbaxa is a product by Cubist Pharmaceuticals Inc.
The Federal regulators on Friday approved a new antibiotic which will fight intra-abdominal and urinary tract infections. The antibiotic is being developed by Lexington’s Cubist Pharmaceuticals Inc., and has a brand name of Zerbaxa. Zerbaxa combines ceftolozane, a new antibiotic, and an existing drug, tazobactam. The drug is to be given as an infusion in hospitals and will be the first in a new generation of drugs which targets a class of Gram negative bacteria which are resistant to most of today’s antibiotic. It will be the first drug which will take on what has been named superbug infections and are believed to cause more than 23000 deaths in US alone. It will be the fourth antibiotic which the agency will approve since May.
Approval of Zerbexa on Friday marks the second antibiotic approval this year for Cubist Pharmaceuticals. The company specializes in antibiotics and it is being acquired by Merck & Co. of Kenilworth, New Jersey for $8.4 billion.
Since the 1990’s the threat of antibiotic resistance has been growing and this problem has been made more acute by overuse of antibiotics. It led Congress to pass a law in 2010 which gives accelerated review and five years of extra marketing exclusivity to antibiotics and antifungal drugs that treat very serious infections. The law also ensures that rivals do not sell copycat products.
Zerbaxa becomes the first drug which has been approved under the new law and it treats Gram-negative bacteria, a group of pathogens that are difficult to be treated and relatively few treatment options. It includes diseases such as meningitis and cholera.
The Infectious Diseases Society of America is racing to get 10 new antibiotics into the market. Antibiotics which has been approved by FDA this year includes, Dalvance from Durata Therapeutics, Orbactiv from The Medicines Co. and another Cubist drug, Sivextro, for common skin infections often acquired in the hospital.
Dr. Edward Cox, director of the FDA’s Office of Antimicrobial Products, said in a statement, “We must continue to help foster the development of new antibacterial drugs and encourage prudent use of existing treatments to conserve their utility.”