The US FDA’s commitment to supporting vital new antibiotics continues with the agency’s decision to give Cubist Pharmacetuicals’ ceftolozane/tazobactam a priority review.
The decision will speed up the review period for the antibiotic, which Cubist is planning to market for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.
It is the second boost for new antibiotics in the US this month after the FDA’s decision to grant fast track status to AstraZeneca’s AZD0914 for the sexually transmitted infection (STI) uncomplicated gonorrhoea.
Both drugs were eligible for these favourable regulatory designations as they are classed as a Qualified Infectious Disease Product (QIDP). This classification was implemented by the FDA as part of the US Generating Antibiotic Incentives Now (GAIN) Act in 2012.
The Act was implemented to support the development of new antibiotic treatments to help combat increasing resistance of infectious diseases to existing treatments, which is a growing public health problem across the world.
The problem has been exacerbated by a lack of new treatments as the area has been somewhat neglected by pharma in recent years due to the poor return on investment offered by antibiotics.
Cubist is one of the few companies at the forefront of this research and ceftolozane/tazobactam is one of its key products, demonstrating it is as effective as current treatment meropenem in clinical studies.
The company’s other investigational treatments include Sivextro (tedizolid phosphate), which is currently under regulatory review in both Europe and the US.