Please login to the form below

Not currently logged in
Email:
Password:

Cubist antibiotic to get priority review in US

FDA will expedite assessment of ceftolozane/ tazobactam

Cubist pharmaThe 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.

Article by
Thomas Meek

20th June 2014

From: Research, Sales, Healthcare

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Videum Health

Videum Health is a premium video platform that offers brands innovative engagement strategies to reach targeted healthcare audiences on a...

Latest intelligence

Is China ready for a pharmaceutical gold rush?
Some describe doing business in China as akin to the 1990s internet boom – so how stable is its future?...
AstraZeneca’s oncology renaissance
Susan Galbraith played a key role in restoring AstraZeneca’s place in cancer drug development – she talks about the future of oncology and why there’s more to be done to...
Navigating the antibiotic resistance crisis
Blue Latitude Health speaks to Tara DeBoer, PhD, Postdoctoral Researcher and CEO of BioAmp Diagnostics to explore the antimicrobial resistance crisis, and learn how a simple tool could support physicians...

Infographics